Drug recall
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD…
FDA recall event 93636 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 93636 |
|---|---|
| Recall numbers | Z-1139-2024 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums |
| Initiation date | Jan 26, 2024 |
| Report date | Feb 21, 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: