BioFire Respiratory Panel 2.1 Recalled Due to Temperature Shipping Excursions
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
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: FDA Class II precautionary recall due to potential performance degradation from temperature excursion during shipping, with no reported illnesses or injuries. The hazard is theoretical, meeting the criterion for a score at most 3, and no specific patient harm has been documented.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BioFire Respiratory Panel 2.1 (RP2.1), an in vitro diagnostic (IVD) panel used to identify respiratory pathogens. Eight kits with Lot Number 1551622 (Part Number 423742) were distributed in Florida and Georgia.
The recall was issued because the products experienced temperature excursions during shipping, meaning they were stored outside the manufacturer's required temperature specifications. This temperature exposure may cause a reduction in device performance.
No illnesses or injuries have been reported in connection with this recall. Customers in the affected states who received these kits should contact BioFire Diagnostics, LLC regarding the recalled products.
The recalled product
- Product
- In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 8
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 (1)
- Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
Distribution
Part of a larger recall action
This product is one of 3 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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