Reported Aug 30, 2023 · Ongoing
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
BioFire Diagnostics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248
Is this the product you have?
- BioFire Respiratory Panel 2.1 (RP2.1)
- REF423742, For FILMARRAY systems, IVD, Rx Only
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch 2 Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch 3 Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch 4 Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch 5 Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch 6 Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch 7 Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch 8 Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch 9 Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch 10 Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch 11 Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch 12 Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch 13 Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch 14 Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch 15 Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch 16 Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch 17 Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch 18 Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch 19 Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch 20 Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch - Amount recalled
- 705 kits (30 pouches/kit)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to manufacturing issue, panels may result in false negative results.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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