Drug recall
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro…
FDA recall event 87934 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 87934 |
|---|---|
| Recall numbers | Z-1903-2021 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel… |
| Initiation date | May 10, 2021 |
| Report date | Jun 30, 2021 |
| Termination date | Dec 15, 2022 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 3002773840 |
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: