BioFire Joint Infection Panel Recalled for Potential Contamination
BioFire Diagnostics is recalling specific lots of the Joint Infection Panel due to potential contamination that could cause false positive test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to potential contamination causing false positive results, which may lead to temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
BioFire Diagnostics, LLC is recalling specific lots of the BioFire Joint Infection (JI) Panel. The recall involves 1,186 units of the multiple-type osteoarticular pathogen nucleic acid in vitro diagnostic (IVD) kit, including model numbers RFIT-ASY-0138 (30 Kit) and RFIT-ASY-0135 (6 Kit).
The recall was initiated due to potential contamination of specific lots of pneumonia and joint infection panels. This contamination could result in false positive test results. The affected products were distributed nationwide in the United States and in numerous countries worldwide.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled products, nor does it report any illnesses, injuries, or deaths associated with the use of these kits.
The recalled product
- Product
- 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…
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 1,186
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 (17)
- Lot Code: UDI Nos 00815381020192 (30 Kit)
- 00815381020208 (6 Kit)
- Model Nos RFIT-ASY-0138 (30 Kit)
- RFIT-ASY-0135 (6 Kit)
- Lot Numbers 0677326
- 0806426
- 0806526
- 1289126
- 1289226
- 1405526
- 1405626
- 1413026
- 1413426
- 1413526
- 1507826
- 1613326
- 1684726
Distribution
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