Home › Device types › DLJ
Calibrators, Drug Specific
FDA product code DLJ · Class 2 · Clinical Toxicology
603
Registered devices
21
Adverse events
5
Recalls
123
510(k) clearances
Devices with this code
Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 — Siemens Healthcare Diagnostics Inc.ARK™ Tramadol Cutoff Calibrator — ARK DIAGNOSTICS INCCAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418 — CAROLINA LIQUID CHEMISTRIES CORPORATIONHydrocodone 100 Semi-Quantitative Calibrators Set — LIN-ZHI INTERNATIONAL, INC.DRI Methadone Metabolite 1000 ng/mL Calibrator — Microgenics CorporationImmunalysis — IMMUNALYSIS CORPCEDIA THC OFT Cutoff Calibrator — Microgenics CorporationCocaine Metabolite 150 DAU Calibrator, Low Calibrator — LIN-ZHI INTERNATIONAL, INC.Cannabinoids DAU Calibrator, Calibrator — LIN-ZHI INTERNATIONAL, INC.CAROLINA LIQUID CHEMISTRIES CORP.® THC50 RGT. KIT BL-410A — CAROLINA LIQUID CHEMISTRIES CORPORATIONEcstasy DAU Calibrator, High Calibrator — LIN-ZHI INTERNATIONAL, INC.Pointe Propoxyphene (PPX) Calibrator (150 ng/mL) Low — HORIBA INSTRUMENTS INCORPORATEDTotal MPA Calibrators — Roche Diagnostics GmbHPointe Cannabinoids (THC) Calibrator (12.5 ng/mL) — HORIBA INSTRUMENTS INCORPORATEDHydrocodone 300 DAU Calibrator, Cutoff Calibrator — LIN-ZHI INTERNATIONAL, INC.Pointe Methadone Calibrator (1000 ng/mL) — HORIBA INSTRUMENTS INCORPORATEDCOBAS FP Free Phenytoin Calibrators — Roche Diagnostics GmbH6-Acetylmorphine DAU Calibrator, High Calibrator — LIN-ZHI INTERNATIONAL, INC.Dimension® SIRO CAL — Siemens Healthcare Diagnostics Inc.Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL) — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT BL-424 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT BL-427 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCannabinoids DAU Calibrator, Calibrator — LIN-ZHI INTERNATIONAL, INC.TUptake Calibrators — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-14 | Ortho-Clinical Diagnostics, Inc. | Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing |
| 2014-02-06 | Lin-Zhi International Inc | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentratio |
| 2011-11-11 | Microgenics Corp | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| 2011-06-08 | Microgenics Corp | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |
| 2010-09-13 | Abbott Laboratories | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. |
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