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Calibrators, Drug Mixture
FDA product code DKB · Class 2 · Clinical Toxicology
213
Registered devices
7
Adverse events
9
Recalls
94
510(k) clearances
Devices with this code
Multi-Analyte DAU Calibrator Set E, Low Calibrator — LIN-ZHI INTERNATIONAL, INC.Synchron — Beckman Coulter, Inc.Validate — Lgc Clinical Diagnostics, Inc.Immunalysis — IMMUNALYSIS CORPImmunalysis — IMMUNALYSIS CORPADVIA® Chemistry Drug Calibrator II — Siemens Healthcare Diagnostics Inc.ARCHITECT — ABBOTT LABORATORIESAlinity — ABBOTT LABORATORIESPointe Multi-Analyte E DAU Cutoff Calibrator — HORIBA INSTRUMENTS INCORPORATEDDRI Multi-Drug Urine Calibrator 4 — Microgenics CorporationLSD CalibrationControl Pack — Roche Diagnostics GmbHSyva® Emit® Ethyl Alcohol 100 mg/dL Calibrator — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® VALP +28 — Siemens Healthcare Diagnostics Inc.Preciset TDM II — Roche Diagnostics GmbHCEDIA Multi-Drug High Calibrator — Microgenics CorporationCEDIA Antibiotic TDM Multi-Cal — Microgenics CorporationDRI Serum Tox Calibrator 3 — Microgenics CorporationImmunalysis — IMMUNALYSIS CORPDRI Multi-Drug Urine Calibrator 2 — Microgenics CorporationARCHITECT — ABBOTT LABORATORIESImmunalysis — IMMUNALYSIS CORPCfas DAT Qualitiative Plus — Roche Diagnostics GmbHPointe Multi-Analyte Set D Urine DAU Low Calibrator — HORIBA INSTRUMENTS INCORPORATEDDRI Drugs of Abuse Low Calibrator — Microgenics Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-13 | Ortho-Clinical Diagnostics, Inc. | Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
| 2014-05-12 | Ortho-Clinical Diagnostics | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference |
| 2012-12-06 | Siemens Healthcare Diagnostics, Inc. | Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned e |
| 2011-10-11 | Lin-Zhi International Inc | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. |
| 2011-08-23 | Lin-Zhi International Inc | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false |
| 2009-08-11 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
| 2009-04-22 | Roche Diagnostics Corp. | The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles. |
| 2009-04-22 | Roche Diagnostics Corp. | The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles. |
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