BioFire Diagnostics, LLC: FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853

Recall number

Z-0296-2019

Recalling firm

BioFire Diagnostics, LLC

Product

FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,

Status

Terminated

Initiated

2018-09-05

Posted

2018-10-30

Terminated

2021-03-22

Reason

Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.

Root cause

Material/Component Contamination

Action

On 09/05/2018 the firm sent an Urgent Customer Advisory Notice to all customers via Federal Express (to US customers) and USPS (to Laboratory Directors for all organizations that have ordered kits) informing them that the firm has identified an increased risk of false positive Proteus results when the BioFire BCID Panel is used with BACT/ALERT Blood Culture Bottles: BACT/ALERT Blood Culture Bottle Catalog No. Description 410851 BACT/ALERT FA Plus 410852 BACT/ALERT FN Plus 410853 BACT/ALERT PF Plus with expiration dates of 2019-05-02 and beyond. The intended function of BACT/ALERT blood culture bottles (culturing viable microorganisms) is not compromised by this anomaly. BACT/ALERT PF Plus Blood Culture Bottles are included in this notification since they share the same lots of some raw materials used to manufacture implicated lots of BACT/ALERT FA Plus and FN Plus Blood Culture Bottles; there are currently no customer complaints regarding this issue for this bottle type. It is unknown if subsequent lots of BACT/ALERT media will also be subject to this risk; however, BioFire and BioMrieux teams are coordinating efforts to resolve this issue. The most probable cause for this risk is the presence of an increased level of nucleic acid from non-viable Proteus in BACT/ALERT Blood Culture Bottles (Table 1). BioFire has confirmed the presence of Proteus nucleic acid in BacT/ALERT bottle lots using an independent PCR/bi-directional sequencing method. The presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms). However, the BioFire BCID Panel detects nucleic acid from viable and non-viable organisms alike. Observed false positives are typically seen as multiple positives with the BioFire BCID Panel because a positive culture is a prerequisite to a BCID test. B

Quantity

18038

Distribution

Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam

Lot, serial or model codes

All lots.

510(k) numbers

["K130914","K143171","K160457","K181493"]

PMA numbers

not on file

Product code

PAM

Firm FEI

3002773840

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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