In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Reported: March 22, 2023 Initiated: February 1, 2023 #Z-1251-2023
Product Description
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
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.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 2 kits
- Distribution
- U.S. Nationwide distribution in the states of FL and GA.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147. Recalled by BioFire Diagnostics, LLC. Units affected: 2 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1251-2023.
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