Z-0296-2019Class II

FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/...

Name: Z-0296-2019 FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/...
Creator: BioFire Diagnostics, LLC
Published: 2018-09-05
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2018-09-05 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086... on 2018-09-05. FDA classified it as Class II and gives the reason as "Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0296-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-05
Posted: 2018-10-30
Terminated: 2021-03-22
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,
Product code: PAM Gram-Positive Bacteria And Their Resistance Markers
Reason for recall: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0296-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0296-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30

Product code PAM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)