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biofire diagnostics, llc

4 recalls on record

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BioFire Diagnostics, LLC — BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Due to increase in false negative results

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BioFire Diagnostics, LLC — BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Contamination to in-vitro diagnostic test may result in false positives.

B
BioFire Diagnostics, LLC — Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Respiratory/sore throat panel test may result in false negative results and control failures.

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BioFire Diagnostics, LLC — BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.