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Clinical Toxicology devices

180 product codes reviewed by the Clinical Toxicology panel. 3,041 510(k) clearances and 395 recalls in the FDA data, 85% of those recalls name a 510(k).

14510(k)s in 12 months
13recalls in 12 months
337recalls that name a 510(k)

Codes with the most recalls

CodeDeviceAll time12 months
JXMEnzyme Immunoassay, Benzodiazepine810
DKZEnzyme Immunoassay, Amphetamine240
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites230
DOFLead, Atomic Absorption215
LDJEnzyme Immunoassay, Cannabinoids150
DJGEnzyme Immunoassay, Opiates132
LCDEnzyme Immunoassay, Gentamicin130
LDPColorimetry, Acetaminophen120
LEHRadioimmunoassay, Vancomycin120
DIPEnzyme Immunoassay, Diphenylhydantoin110
DIFDrug Mixture Control Materials100
DJREnzyme Immunoassay, Methadone90
DKBCalibrators, Drug Mixture90
DLZEnzyme Immunoassay, Phenobarbital90
KLSEnzyme Immunoassay, Theophylline80

Active product codes

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
NFTTest, Amphetamine, Over The Counter260
DJGEnzyme Immunoassay, Opiates232
DOFLead, Atomic Absorption205
LBZEnzyme Immunoassay, Quinidine202
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method201
DJCThin Layer Chromatography, Methamphetamine210
KLREnzyme Immunoassay, Lidocaine201
LDPColorimetry, Acetaminophen210
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs201
MXASystem, Test, Breath Nitric Oxide210
NFWTest, Cannabinoid, Over The Counter210
NGLTest, Opiates, Over The Counter210
QDRPlazomicin Test System, Immunoassay201

Latest recalls in this panel

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Open, Classified		 DOFK052549
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Open, Classified		 LBZK011605
Aug 17, 2026Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Open, Classified		 LBZK922913
Aug 4, 2026Siemens Healthcare Diagnostics, Inc.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Open, Classified		 LFGK821743
Aug 4, 2026Siemens Healthcare Diagnostics, Inc.
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Open, Classified		 KLRK801204
Apr 17, 2026Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes
Open, Classified		 DOFK052549
Apr 17, 2026Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4
Open, Classified		 DOFK142705
Apr 17, 2026Magellan Diagnostics, Inc.
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Tes
Open, Classified		 DOFK052549
Dec 1, 2025GET TESTED INTERNATIONAL AB
Biological Age & Longevity Test
Open, Classified		 QDRNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Drug Test Small (4 substances)
Open, Classified		 DJGNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Illegally Marketed
Open, Classified		 DJGNone listed
Dec 1, 2025GET TESTED INTERNATIONAL AB
Alcohol (ALC) Test Saliva
Open, Classified		 DICNone listed
Nov 21, 2025Magellan Diagnostics, Inc.
The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Co
Open, Classified		 DOFK052549
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products
Open, Classified		 DIHNone listed
Jul 17, 2025Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemist
Open, Classified		 DIHNone listed
Jul 2, 2025Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine.
Open, Classified		 DJGK062460
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Open, Classified		 LEHK043386
Jan 10, 2025QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a
Open, Classified		 LFMK942610
Jan 10, 2025QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a
Open, Classified		 LFMK942610
Nov 7, 2023Family Dollar Stores, Llc.
AT HOME MARIJUANA TEST STRIP, SKU 900752
Open, Classified		 LDJK140546
Nov 3, 2023Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
Open, Classified		 DOFK052549
Oct 23, 2023Universal Meditech Inc.
PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
Open, Classified		 ORANone listed
May 30, 2023Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemis
Open, Classified		 DLJNone listed

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