Drug recall
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and…
FDA recall event 79514 · Class II · BioFire Diagnostics, LLC
Key facts
| Event ID | 79514 |
|---|---|
| Recall numbers | Z-1513-2018 |
| Recalling firm | BioFire Diagnostics, LLC |
| Product type | Devices |
| Products | FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles. |
| Initiation date | Mar 14, 2018 |
| Report date | May 2, 2018 |
| Termination date | Oct 24, 2018 |
| 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: