BioFire Respiratory Panel 2.1 may produce false negative results
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a diagnostic product with risk-of-harm potential due to false negative results. No illnesses or injuries are reported in the source text, so the score is capped at 3 per the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The FDA is recalling BioFire Respiratory Panel 2.1 (RP2.1, REF 423742), an in vitro diagnostic test used with FILMARRAY systems, manufactured by BioFire Diagnostics, LLC.
A manufacturing issue has been identified that may cause these diagnostic panels to return false negative results. False negative results mean tests could indicate a patient does not have a respiratory infection when one may actually be present.
The recall affects approximately 705 kits (30 pouches per kit) distributed to healthcare facilities in 24 U.S. states and internationally to Canada, India, Japan, Singapore, and Colombia. Specific affected lot numbers and kit numbers are listed in the FDA recall database.
Healthcare providers and patients using affected kits should consult BioFire Diagnostics and the FDA recall notice for guidance on test validity and next steps.
The recalled product
- Product
- BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- false-negative
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23
- Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23
- Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23
- Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23
- Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23
- Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23
- Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23
- Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23
- Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23
- Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23
- Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23
- Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23
- Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23
- Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23
- Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23
- Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23
- Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23
- Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23
- Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23
- Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23
Distribution
Distributed in 24 states:
- CA
- CO
- CT
- FL
- GA
- IA
- IL
- IN
- LA
- MA
- MI
- MO
- MT
- NC
- NE
- NJ
- NM
- NY
- OH
- OK
- PA
- TN
- UT
- WV
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