BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reported: June 4, 2025 Initiated: April 30, 2025 #Z-1877-2025
Product Description
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Reason for Recall
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 30 kits
- Distribution
- International distribution in the country of Singapore.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems. Recalled by BioFire Diagnostics, LLC. Units affected: 30 kits.
Why was this product recalled? ▼
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1877-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11