FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
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: This is an FDA Class II medical device with a manufacturing defect that creates risk of harm through false negative diagnostic results, potentially leading to missed pneumonia diagnoses. No illnesses, injuries, or hospitalizations have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel (Pneumo) kits, REF RFIT-ASY-0145, due to a manufacturing issue. The defect may cause the diagnostic panels to produce false negative results.
FilmArray Pneumonia Panels are in vitro diagnostic devices used by healthcare providers to detect pneumonia-causing pathogens. False negative results could delay or prevent correct diagnosis of pneumonia, a serious respiratory infection.
The recalled product includes 24 kits containing 30 pouches each, with Pouch Lot # 2NBT22 and Kit # 2187822. The product was distributed to healthcare facilities in multiple U.S. 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) and internationally to Canada, India, Japan, Singapore, and Colombia.
Healthcare providers and patients who may have been affected should be aware of this potential diagnostic error. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative
- manufacturing-defect
- missed-diagnosis
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 (2)
- Pouch Lot # 2NBT22 /Kit # 2187822
- UDI-DI: UDI: 00815381020482
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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