FDA Recall Database: Class II Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30… by BioFire Diagnostics, LLC

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is BioFire Diagnostics, LLC and the affected product is described in FDA's record as: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.. FDA's stated reason for the recall is: Contamination to in-vitro diagnostic test may result in false positives.. The recall is tracked under FDA recall number Z-2067-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. -- and the recall number Z-2067-2026. If it matches, stop using or distributing it and contact BioFire Diagnostics, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

BioFire Diagnostics, LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to BioFire Diagnostics, LLC: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.) and recall number Z-2067-2026, then follow BioFire Diagnostics, LLC's recall instructions.

Has BioFire Diagnostics, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to BioFire Diagnostics, LLC, including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2067-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions