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DRUG CONTROL - LEVEL 2 (TDM CONTROL 2)
RANDOX LABORATORIES LIMITED · Model HD1668 · UDI-DI 05055273203585
DIF
Prescription
10
510(k) clearances
6
Adverse events
10
Recalls
38
Facilities
Description
This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-30 | MEDLINE INDUSTRIES, LP - Northfield | Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. |
| 2019-04-09 | QUIDEL CARDIOVASCULAR INC | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Me |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usin |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usin |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usin |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usin |
| 2017-09-22 | Ortho-Clinical Diagnostics | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when usin |
| 2013-09-23 | Alere San Diego, Inc. | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the |
| 2011-08-05 | Lin-Zhi International Inc | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators. |
| 2005-06-27 | Abbott Laboratories MPG | The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.