BioFire Diagnostics recalls Generic Name: BioFire¿ Joint Infection
FDAHome & Health recallNo official product photo was published for this recall.
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the hazard?
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
What's affected
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
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