Drug recall
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY…
FDA recall event 94992 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 94992 |
|---|---|
| Recall numbers | Z-2514-2024 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI)… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| Initiation date | May 16, 2024 |
| Report date | Aug 14, 2024 |
| 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: