The Recall Desk
ModerateFDA (Devices)·Z-1251-2023·Announced 2023-03-22

BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues

BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.

What this means for you

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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is reduced diagnostic performance from temperature exposure, which is potential rather than manifested in actual harm.

Plain-English summary

BioFire Diagnostics, LLC is recalling the BioFire BCID2 Panel, an in vitro diagnostic test kit used in clinical laboratories. The recall was initiated because products were stored outside their required temperature specifications during shipment, a result of shipping delays.

Temperature excursions can reduce the diagnostic performance of the affected test panels. This condition may affect the accuracy or reliability of test results produced by these kits.

The affected products were distributed nationwide to healthcare facilities in Florida and Georgia. No illnesses or injuries have been reported in connection with this recall.

Healthcare providers and laboratories that received affected products should discontinue use and contact BioFire Diagnostics for replacement products and additional guidance.

The recalled product

Product
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Manufacturer
BioFire Diagnostics, LLC
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
2

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: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · BioFire Diagnostics, LLC

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Same hazard · temperature excursion

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