Drug recall
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical…
FDA recall event 76665 · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Event ID | 76665 |
|---|---|
| Recall numbers | Z-1765-2017 |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Product type | Devices |
| Products | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have… |
| Initiation date | Mar 7, 2017 |
| Report date | Apr 19, 2017 |
| Termination date | Jun 14, 2019 |
| City | Bridgend |
| Country | United Kingdom |
| FEI number | 3007111389 |
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: