Panels › Hematology
Hematology devices
267 product codes reviewed by the Hematology panel. 4,197 510(k) clearances and 1,032 recalls in the FDA data, 71% of those recalls name a 510(k).
12510(k)s in 12 months
44recalls in 12 months
736recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 247 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 103 | 1 |
| NJT | Immunohistochemistry Reagents And Kits | 92 | 1 |
| GJS | Test, Time, Prothrombin | 73 | 0 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 43 | 0 |
| GKP | Instrument, Coagulation, Automated | 31 | 0 |
| OYE | Flow Cytometric Reagents And Accessories. | 26 | 1 |
| GIO | Tube, Collection, Capillary Blood | 25 | 13 |
| KHE | Reagent, Occult Blood | 19 | 2 |
| GGN | Plasma, Coagulation Control | 16 | 2 |
| JPK | Mixture, Hematology Quality Control | 16 | 0 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 14 | 2 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 14 | 0 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 13 | 2 |
| GIF | Diluent, Blood Cell | 13 | 1 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | 1 | 0 | 13 |
| GKZ | Counter, Differential Cell | 2 | 4 | 1 |
| LCO | Platelet Factor 4 Radioimmunoassay | 2 | 0 | 4 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | 1 | 2 |
| GFO | Activated Partial Thromboplastin | 2 | 1 | 2 |
| LJX | Test, Urine Leukocyte | 1 | 0 | 3 |
| POV | Semen Analysis Device | 2 | 1 | 2 |
| GGN | Plasma, Coagulation Control | 2 | 0 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 | 0 | 2 |
| JBP | Activated Whole Blood Clotting Time | 2 | 0 | 2 |
| KHE | Reagent, Occult Blood | 2 | 0 | 2 |
| GGW | Test, Time, Partial Thromboplastin | 2 | 1 | 0 |
| GIF | Diluent, Blood Cell | 1 | 0 | 1 |
| JOY | Device, Automated Cell-Locating | 2 | 0 | 1 |
| JOZ | System, Automated Platelet Aggregation | 2 | 0 | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 | 1 | 0 |
| JPH | Test, Erythrocyte Sedimentation Rate | 1 | 0 | 1 |
| JWO | Device, Blood Volume Measuring | 2 | 1 | 0 |
| KFF | Assay, Heparin | 2 | 1 | 0 |
| LCP | Assay, Glycosylated Hemoglobin | 2 | 0 | 1 |
| NJT | Immunohistochemistry Reagents And Kits | 1 | 0 | 1 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 2 | 1 | 0 |
| NRF | Material, Quality Control, Semen Analysis | 2 | 0 | 1 |
| OQX | Self-Contained Blood Grouping | 2 | 0 | 1 |
| OYE | Flow Cytometric Reagents And Accessories. | 2 | 0 | 1 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) Open, Classified |
LCO | K170854 |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Open, Classified |
LCO | K170854 |
| Oct 7, 2026 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC SEDIPLAST;
Model/Catalog Numbers: S-100 and S-1000; Open, Classified |
JPH | K840500 |
| Aug 28, 2026 | Diagnostica Stago, Inc. STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
qualitative and quantitative factor deficiency test Open, Classified |
GGP | K913424 |
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Control, Model Number 5D-44905 Open, Classified |
GGN | None listed |
| Jun 16, 2026 | Accriva Diagnostics, Inc. directCHECK ACT-LR whole blood quality control, level 2
Model/Catalog Number: DCGLR-2 Open, Classified |
GGN | K202101 |
| May 12, 2026 | Aniara Diagnostica LLC ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Open, Classified |
LCO | K071255 |
| May 6, 2026 | DFI Co., Ltd. One Step UTI in vitro diagnostic test
REF: 3374 Open, Classified |
LJX | None listed |
| Mar 19, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest D-Di
Product Name: STA Liatest D-Di
Model/Catalog Number: REF 00515
Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative det Open, Classified |
DAP | K162227 |
| Mar 3, 2026 | Diagnostica Stago, Inc. Brand Name: STA Liatest Free Protein S
Product Name: STA Liatest Free Protein S
Model/Catalog Number (REF): 00516
Product Description: The STA - Liatest Free Protein S kits are intended for use on STA Open, Classified |
GGP | K010963 |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. Male Fertility Sperm Test for Home Use (Cassette) Open, Classified |
NRF | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. LotFancy Urinary Tract Infection Urine (UTI) Test Strips;
PALINOIA UTI-10 PARAMETER REAGENT STRIPS;
Vaunn Medical 8-in-1 Urinalysis Reagent Strip;
JNW Direct 4-in-1 UTl Urinalysis Test Strips;
Urinify Open, Classified |
LJX | None listed |
| Jan 30, 2026 | Beckman Coulter, Inc. COULTER DxH Diluent, REF 628017
COULTER DxH ECO Diluent REF C67250
For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all Un Open, Classified |
GIF | None listed |
| Jan 15, 2026 | Instrumentation Laboratory The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of
heparin therapy. Open, Classified |
GFO | K060688 |
| Jan 14, 2026 | Diagnostica Stago, Inc. Asserachrom HPIA.
Model/Catalog Number: 00615.
The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated Open, Classified |
LCO | K003767 |
| Dec 17, 2025 | Instrumentation Laboratory HemosIL SynthAFax. Partial Thromboplastin Time Tests. Open, Classified |
GFO | K955638 |
| Dec 3, 2025 | Accriva Diagnostics, Inc. Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System Open, Classified |
JBP | K960749 |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sperm Test Open, Classified |
POV | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Urinary Tract Infection Test Open, Classified |
LJX | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Sperm Test Open, Classified |
POV | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB MPOX Test Open, Classified |
NJT | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Fecal Occult Blood Test Open, Classified |
KHE | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Diabetes HbA1c Test Open, Classified |
LCP | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB D-Dimer Test Open, Classified |
DAP | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Blood Type Test Open, Classified |
OQX | None listed |
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