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Clinical Chemistry devices
409 product codes reviewed by the Clinical Chemistry panel. 13,074 510(k) clearances and 3,481 recalls in the FDA data, 72% of those recalls name a 510(k).
71510(k)s in 12 months
180recalls in 12 months
2,491recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 564 | 10 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 218 | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 185 | 33 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 171 | 14 |
| NBW | System, Test, Blood Glucose, Over The Counter | 137 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 95 | 2 |
| CGA | Glucose Oxidase, Glucose | 89 | 0 |
| JIX | Calibrator, Multi-Analyte Mixture | 73 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 63 | 3 |
| MMI | Immunoassay Method, Troponin Subunit | 56 | 0 |
| JIT | Calibrator, Secondary | 55 | 1 |
| LFR | Glucose Dehydrogenase, Glucose | 51 | 0 |
| JGS | Electrode, Ion Specific, Sodium | 48 | 0 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 47 | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 46 | 1 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 1 | 33 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 9 | 14 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 2 | 6 | 14 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 0 | 10 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 6 | 4 |
| QJI | Interoperable Automated Glycemic Controller | 2 | 10 | 0 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 2 | 3 | 5 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 2 | 1 | 5 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 1 | 4 |
| OHQ | Multi-Analyte Controls Unassayed | 1 | 0 | 5 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 1 | 3 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | 1 | 0 | 4 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 0 | 4 |
| NBC | Test, Natriuretic Peptide | 2 | 4 | 0 |
| PDJ | Hemoglobin A1c Test System | 2 | 2 | 2 |
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | 2 | 0 | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 | 1 |
| CKG | Radioimmunoassay, Acth | 2 | 0 | 3 |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 2 | 0 | 3 |
| NRH | System, Breath Measurement | 1 | 0 | 3 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | 0 | 3 |
| QWZ | Prognostic Test For Assessment Of Chronic Kidney Disease Progression | 2 | 0 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 | 1 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | 0 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | 0 | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | 0 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 1 | 1 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | 0 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 | 0 | 2 |
| KQO | Automated Urinalysis System | 1 | 0 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 0 | 2 |
| MRG | System, Test, Vitamin D | 2 | 0 | 2 |
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | 1 | 0 | 2 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 1 | 0 | 2 |
| PHV | Continuous Glucose Monitor Retrospective Data Analysis Software | 1 | 0 | 2 |
| QBV | Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | 1 | 2 | 0 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 2 | 2 | 0 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | 2 | 2 | 0 |
| CDA | Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin | 1 | 0 | 1 |
| CFR | Hexokinase, Glucose | 2 | 1 | 0 |
| CGA | Glucose Oxidase, Glucose | 2 | 1 | 0 |
| CGF | Radioimmunoassay, Estrone | 1 | 0 | 1 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 2 | 1 | 0 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 0 | 1 |
| CHM | Radioimmunoassay, Total Estrogens In Pregnancy | 1 | 0 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 1 | 0 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 1 | 0 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 1 | 0 |
| JFY | Enzymatic Method, Creatinine | 2 | 1 | 0 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 1 | 0 |
| JID | Photometric Method, Ammonia | 1 | 1 | 0 |
| JIJ | Wet Ash Method, Protein-Bound Iodine | 1 | 0 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | 0 | 1 |
| JIT | Calibrator, Secondary | 2 | 0 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 0 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 0 | 1 |
| JJH | Clinical Sample Concentrator | 1 | 0 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 0 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 2 | 1 | 0 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 | 0 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 0 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 0 | 1 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 1 | 0 | 1 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 2 | 0 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 0 | 1 |
| LNW | Paper, Obstetric Ph | 1 | 0 | 1 |
| LPT | System, Test, Urinary Methylmalonic Acid | 2 | 0 | 1 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | 0 | 1 |
| MLM | Enzyme Immunoassay, Tracrolimus | 2 | 0 | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 1 | 0 |
| NAQ | Lipoprotein, High Density, Hdl, Over The Counter | 1 | 0 | 1 |
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | 2 | 0 | 1 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | 0 | 1 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 1 | 0 | 1 |
| PIG | Acute Kidney Injury Test System | 2 | 0 | 1 |
| PQO | Anti-Müllerian Hormone Test System | 2 | 0 | 1 |
| QWH | Prognostic Test For Development Or Progression Of Preeclampsia | 2 | 0 | 1 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | 2 | 1 | 0 |
| SFU | Glucose Range Monitoring System | 2 | 1 | 0 |
| SHB | Creatinine Test System For At Home Prescription Use | 2 | 1 | 0 |
| SJD | Integrated Continuous Glucose Ketone Monitoring System | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2026 | Luminex Corporation LIAISON PLEX Gram-Negative Blood Culture Assay
Catalog No. 20-005-303 Open, Classified |
NSU | K243013 |
| Oct 30, 2026 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018 Open, Classified |
QFG | K223213 K233044 +3 |
| Oct 27, 2026 | BioMerieux SA EMAG system
Model/Catalog Number: 418591/418591U
Product Description: Nucleic acid sample preparation instrument IVD, automated Open, Classified |
JJH | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 3, REF:AE623X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 2
REF: AE622X Open, Classified |
OHQ | None listed |
| Oct 22, 2026 | TECHNO-PATH MANUFACTURING LTD. Techno-Path Multichem AE Unassayed Level 1
REF:AE621X Open, Classified |
OHQ | None listed |
| Oct 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Open, Classified |
JQC | None listed |
| Oct 21, 2026 | Beckman Coulter, Inc. ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Open, Classified |
JQC | None listed |
| Oct 21, 2026 | Medtronic MiniMed, Inc. CareLink Clinic, REF: MMT-7350 Open, Classified |
PHV | None listed |
| Oct 21, 2026 | Greiner Bio-One North America, Inc. Brand Name: VACUETTE
Product Name: LH Lithium Heparin Separator
Model/Catalog Number: 454008P
Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 7 Open, Classified |
JKA | K960857 |
| Oct 15, 2026 | Beckman Coulter, Inc. IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997;
IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684;
IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B4899 Open, Classified |
KQO | K022774 K210127 +1 |
| Oct 15, 2026 | Beckman Coulter, Inc. DxU 840m Iris, REF: C76947;
DxU 850m Iris, REF: C49513 Open, Classified |
KQO | K022774 K210127 +1 |
| Oct 15, 2026 | Radiometer Medical ApS The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point Open, Classified |
CHL | K041874 |
| Oct 15, 2026 | Microgenics Corporation MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF:
OPRO-101;
MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP Open, Classified |
JJY | None listed |
| Oct 5, 2026 | Medtronic MiniMed, Inc. Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump inte Open, Classified |
QFG | K253743 |
| Oct 2, 2026 | Beckman Coulter Inc. DxC 500 AU Clinical Chemistry Analyzers:
1. AU w/out ISE, Part No. C63519
2. AU w/ISE, Part No. C63520 Open, Classified |
JJE | K220977 |
| Oct 2, 2026 | Beckman Coulter Inc. DxC 500i Clinical Analyzer Modules:
1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522
2. DxC 500 AU Module, DxC 500i, Part No. C63521
3. Access 2 Module, DxC 500i, Part No. C13252 Open, Classified |
JJE | K242190 |
| Oct 1, 2026 | Beckman Coulter Mishima K.K. Systems/units containing affected software/SQL
BECKMAN COULTER CHEMISTRY ANALYZER AU480
REF / UDI-DI code:
B96692 / 14987666542965
B96693 / 14987666542972
B12183 / 14987666540671
The AU480 Chemistry Open, Classified |
JJE | K981743 |
| Sep 29, 2026 | Tandem Diabetes Care, Inc. Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 0038915247 Open, Classified |
QFG | K201214 K203234 +1 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;
Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;
Alere hCG Cassette (25mIU/mL) in Open, Classified |
JHI | K993317 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527;
McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000;
Henry Schein One Step+ hCG Urine Strip Test, Open, Classified |
JHI | K993203 |
| Sep 25, 2026 | Alere San Diego, Inc. Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;
Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;
Henry Schein One Step+ hCG Combo test in S Open, Classified |
JHI | K993065 |
| Sep 25, 2026 | Alere San Diego, Inc. McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;
Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;
Fisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC- Open, Classified |
JHI | K062361 |
| Sep 14, 2026 | Nuclein LLC Brand Name: DASH Rapid PCR Instrument
Product Name: DASH Rapid PCR Instrument
Model/Catalog Number: SG-0002
Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6
Product Description: The DASH Rapid PCR Instrum Open, Classified |
NSU | K241652 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. Open, Classified |
PZI | None listed |
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