Drug recall
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
FDA recall event 74932 · Class III · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Event ID | 74932 |
|---|---|
| Recall numbers | Z-2782-2016 |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Product type | Devices |
| Products | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range). |
| Initiation date | Jul 11, 2016 |
| Report date | Sep 21, 2016 |
| Termination date | May 9, 2017 |
| City | Jamestown |
| State | NY |
| Country | United States |
| FEI number | 1318354 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: