Recall Z-1252-2023— BioFire Diagnostics, LLC
Class II · Ongoing
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2023-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742. Reason: Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-01
- Firm location
- Salt Lake City, UT, United States
Product description
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Reason for recall
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Data sourced from openFDA. This site is unofficial and independent of the FDA.