Agency classClass IIOur severity:High FDA (Devices)·Z-1157-2021·Announced 2021-03-10

BioFire Film Array BCID Panels Recalled for False Positive Risk

BioFire Diagnostics is recalling Film Array BCID Panels due to an increased risk of false positive Pseudomonas aeruginosa results when used with specific BD BACTEC vials.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where the hazard is a false positive result, and no specific injuries or illnesses have been reported in the source text.

Plain-English summary

BioFire Diagnostics, LLC is recalling 21,922 kits of the Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID) and Film Array BCID2 Panels. The affected products are identified by Part Numbers RFIT-ASY-0126 and RFIT-ASY-0127. The recall covers all non-expired lots of these panels if they are used with specific BD BACTEC Culture Media vials, specifically Catalog Nos. 442023 and 442020.

The recall was initiated because the firm identified an increased risk of false positive Pseudomonas aeruginosa results when the BCID or BCID2 Panels are used with the specified BD BACTEC blood culture vials. This issue may lead to incorrect diagnostic results for patients.

The affected products were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Healthcare facilities and laboratories should stop using the affected panels with the specified BD BACTEC vials and contact BioFire Diagnostics for further instructions.

The recalled product

Product: Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093…
Manufacturer: BioFire Diagnostics, LLC
Category: Medical Device — In Vitro Diagnostics
Hazard: false-positive-result
Affected units: 21,922

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 (2)

All non-expired BCID and BCID2 Panel lots
if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · BioFire Diagnostics, LLC

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Same hazard · false positive result