Home › Device types › DKB
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
Preciset DAT Plus II — Roche Diagnostics GmbHMulti-Analyte DAU Calibrator Set D, Intermediate Calibrator — LIN-ZHI INTERNATIONAL, INC.Immunalysis — IMMUNALYSIS CORPCfas DAT Qualitiative Plus — Roche Diagnostics GmbHADVIA® Chemistry Drug Calibrator II — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCAlinity — ABBOTT LABORATORIESMulti-Analyte DAU Calibrator Set B, Cutoff Calibrator — LIN-ZHI INTERNATIONAL, INC.Immunalysis — IMMUNALYSIS CORPCEDIA Negative Calibrator — Microgenics CorporationDRI Multi-Drug Urine Calibrator 2 — Microgenics CorporationMulti-Analyte DAU Calibrator Set E, Low Calibrator — LIN-ZHI INTERNATIONAL, INC.CEDIA Antibiotic TDM Multi-Cal — Roche Diagnostics GmbHADVIA® Chemistry Negative Drug Urine Calibrator — Siemens Healthcare Diagnostics Inc.Immunalysis — IMMUNALYSIS CORPARCHITECT — ABBOTT LABORATORIESPointe Multi-Analyte Set D Urine DAU Intermediate Calibrator — HORIBA INSTRUMENTS INCORPORATEDPointe Multi-Analyte E DAU Negative Calibrator — HORIBA INSTRUMENTS INCORPORATEDDRI Serum Tox Negative Calibrator — Microgenics CorporationDRI Multi-Drug Urine Calibrator 3 — Microgenics CorporationADVIA® Chemistry TOX CAL 1 — Siemens Healthcare Diagnostics Inc.Immunalysis — IMMUNALYSIS CORPLSD CalibrationControl Pack — Roche Diagnostics GmbH
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.