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Detectabuse
BIOCHEMICAL DIAGNOSTICS INC · Model 18003079 · UDI-DI 00810042680418
DIF
Prescription
10
510(k) clearances
6
Adverse events
10
Recalls
38
Facilities
Description
CHRONOS MENU B, +50%,20ml
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.