Drug recall
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)
FDA recall event 91892 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 91892 |
|---|---|
| Recall numbers | Z-1392-2023 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. |
| Initiation date | Mar 8, 2023 |
| Report date | Apr 26, 2023 |
| 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: