Every recall we track for BioFire Diagnostics, LLC — 43 in all — plus the complaints and injury reports the public filed about them.
BioFire recalls Respiratory Panel 2.1 (RP2.1) REF 423742 due to increased false negative results in PCR tests. Affected units have UDI code 00815381020529.
BioFire recalls 30-test Joint Infection Panel REF: RFIT-ASY-0138 due to contamination risk causing false positives in diagnostic tests. Affected units include specific lot numbers.
BioFire recalls respiratory/sore throat test panels with risk of false negatives and control failures. Affected units include REF: 42348: 2215125 lot numbers.
BioFire Diagnostics recalls Respiratory Panel 2.1 kits due to false negative results and control failures from pouch chemistry movement. Affected kits have specific UDI and lot numbers.
BioFire Diagnostics recalls Respiratory Panel 2.1 plus Kit (REF: 423740) for possible false negative results from manufacturing errors. Affected units may need replacement.
BioFire Diagnostics recalls Pneumoplus pneumonia test panels due to increased risk of false negatives from control failures. Affected units have specific UDI and lot numbers.
BioFire recalls FILMARRAY TORCH MODULE BOX units with specific serial numbers (2022-2024) that may report false positive Salmonella, Giardia, Norovirus, or false negative MRSA results due to calibration issues.
BioFire Diagnostics recalls FILMARRAY 2.0 instruments from May 2022-May 2024 that may report false positive Salmonella, Giardia, and Norovirus results due to calibration issues.
BioFire recalls BCID2 Blood Culture Panel for FILMARRAY Systems when used with specific culture media lots. False positive Serratia marcescens results may lead to incorrect patient treatment.
BioFire Diagnostics recalls pneumonia test panels due to potential delayed results from manufacturing issues. Affected units have specific lot numbers and expiration dates.
BioFire Diagnostics recalls its Pneumonia Panel Plus due to potential delayed test results from manufacturing control failures. Affected units have specific lot numbers and expiration dates.
BioFire Diagnostics recalls GI test kits that may give false positive Vibrio results when used with Remel Cary Blair transport medium. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
BioFire Diagnostics recalls BCID2 Blood Culture Panel when used with specific BD BACTEC vials due to false positive Candida tropicalis results. Affected units may show incorrect fungal detection.
BioFire Diagnostics recalls GI panels with potential for false positive Norovirus results. Affected kits include RFIT-ASY-0116 (30 tests) and RFIT-ASY-0104 (6 tests).
BioFire Diagnostics recalls FilmArray Pneumonia Panel (Pneumo) kits due to potential false positive results. Affected kits have specific UDI numbers and were sold as Rx-only tests.
BioFire Diagnostics recalls Pneumonia Panel Plus (Pneumoplus) kits due to potential false positive results. Affected kits include all unexpired lots with UDI 00815381020314.
BioFire Diagnostics recalls GI Panel due to potential false negatives causing inappropriate antibiotic use or delayed treatment. Affected kits have specific lot numbers and expiration dates.
BioFire recalls Respiratory Panel 2.1 kits that may give false negative results, risking incorrect antibiotic use or delayed treatment for infections.
BioFire recalls Torch Base (HTFA-ASY-0104) due to increased risk of power switch degradation causing potential short circuits or failure. Affected units have serial numbers listed in the recall notice.
BioFire Diagnostics recalls BCID2 Blood Culture Panel REF RFIT-ASY-0147 with Maine Molecular Quality Controls control panels. Affected units may show C. tropicalis as 'Not Detected' due to assay errors. Contact for remedy.
BioFire Diagnostics recalls FilmArray Pneumonia Panel (Pneumo) REF: RFIT-ASY-0145 due to potential false negative results in pneumonia testing.
BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) with REF 423742 due to potential false negative results. Affected units have specific lot numbers and expiration dates.
BioFire recalls FILMARRAY GI Panel software versions before FLM2-SFW-0040 v2.0.3.1 that may cause false positive Cryptosporidium results. Affected units include specific model numbers and serial ranges.
BioFire Diagnostics recalls FilmArray GI Panel kits with possible false negative results due to manufacturing issues. Affected kits include specific lot numbers and model.
BioFire Diagnostics recalls FilmArray GI Panel (REF RFIT-ASY-011:1674322) due to temperature excursions during shipping that may reduce diagnostic performance. Affected units were sold with specific lot numbers.
BioFire Diagnostics recalls Respiratory Panel 2.1 (RP2.1) due to temperature excursions during shipping delays that could reduce test performance. Affected units may need retesting or replacement.
BioFire Diagnostics recalls BCID2 IVD Panel due to temperature excursions during shipping delays that may reduce performance. Affected units include specific lot numbers and model.
BioFire recalls BCID2 blood culture panels with possible false Acinetobacter calcoaceticus-baumannii complex results due to non-viable contamination in vials. Affected panels expire by April 30, 2022.
BioFire Diagnostics recalls FilmArray BCID Panel product pouches with part numbers RFIT-ASY-0126/0127 that may cause false negative blood culture results due to manufacturing errors.
BioFire Diagnostics recalls Pneumoplus test kits with specific part numbers due to increased false negative results after 6 months of use. Affected kits may not detect pneumonia accurately.
BioFire Diagnostics recalls pneumonia test kits that may give false negative results after 6 months of use. Affected kits have specific part numbers and serial codes. Stop using if expired.
BioFire recalls BCID2 Panel (REF RFIT-ASY-0147) due to potential false negatives in blood culture tests. Affected units have pouches with wrong packaging material. Contact for remedy.
BioFire Diagnostics recalls Pneumonia Panel (Penumo) REF RFIT-ASY-014: elevated false positives/negatives and control failures due to manufacturing issues. Affected units include specific lot numbers and model.
BioFire recalls BCID2 Panels used with specific BD BACTEC blood culture vials, risking false Pseudomonas aeruginosa results. Affected units may need retesting or alternative vials.
BioFire Diagnostics recalls Gram-Negative Bacteria Blood Culture Panels that may give false Pseudomonas aeruginosa results when used with certain BD BACTEC vials. Affected units include specific model numbers and lots.
BioFire Diagnostics recalls FilmArray BCID Panel (RFIT-ASY-0127) used with specific BACT/ALERT blood culture bottles due to risk of false positive Proteus results, potentially leading to improper antibiotic treatment.
BioFire recalls FilmArray BCID Panel (RFIT-ASY-0126) used with specific BACT/ALERT blood culture bottles. False positive Proteus results may cause improper antibiotic treatment. Affected units have UDI: 00815381020086.
BioFire Diagnostics recalls GI Panel kits with false negative results that could lead to incorrect treatment and serious health issues. Affected kits have specific UDI and expiration dates.
BioFire Diagnostics recalls FilmArray BCID Panels that may cause false positive results for Enterobacteriaceae and E. coli when used with specific blood culture bottles. Affected units include certain model numbers and lots.
BioFire Diagnostics recalls GI Panel devices due to elevated false positives for Campylobacter and Cryptosporidium. Affected units have expiration dates from October 2019 onward. No remedy specified in recall notice.
BioFire Diagnostics recalls specific FilmArray Meningitis/Encephalitis panels due to potential false positives for HSV-1. Affected kits may require replacement to avoid incorrect test results.
BioFire Diagnostics recalls FilmArray Blood Culture Identification kits that may give false positive results for Proteus when used with certain blood culture bottles. Affected kits include specific catalog numbers and bottle types.
BioFire Diagnostics recalls FilmArray BCID Blood Culture Panels with specific BD BACTEC bottles, risking false Proteus results. Affected units include catalog numbers RFIT-ASY-0126 and RFIT-ASY-0127 with certain bottle lots.
