Z-1133-2019Class II

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used...

Name: Z-1133-2019 FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used...
Creator: BioFire Diagnostics, LLC
Published: 2019-03-07
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2019-03-07 / Terminated / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle... on 2019-03-07. FDA classified it as Class II and gives the reason as "Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain 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-1133-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Posted: 2019-04-12
Terminated: 2022-08-24
Recalling firm: BioFire Diagnostics, LLC
Product: FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, 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: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 03/07/19, Urgent: Medical Device Recall (Correction) notices were mailed to customers. Customers were informed that the false positive results are primarily Enterobacteriaceae results with a lower rate of concurrent E. coli results. If the affected BCID panel is used with BACT/ALERT blood culture bottles from the lots listed, then positive results for Escherichia coli and Enterobacteriaceae (if occurring without a specific genus/species reported other than E. coli; i.e. negative for all of the following: Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and Serratia marcescens) should be confirmed by another method prior to reporting the test results. Confirmation is not required if the Enterobacteriaceae detected result is accompanied by a detected result for Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, or Serratia marcescens. Customers were asked to complete and return Acknowledgement of Receipt forms.
Quantity in commerce: 20350
Distribution: MA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM
Product codes and lots: All lots of BCID Panels, when used with the following blood culture bottles, Part Number/Lot Numbers:410851/4052663, 4052639, 4052640, 4052599, 4052598, 4052547, 4052546, 4052471, 4052472, 4052799, 4052800, 4052815, 4052816; 410852/4052871, 4052872, 4052459, 4052458, 4052565, 4052564, 4052705, 4052704, 4052735, 4052617, 405261; 410853/4052717, 4052718, 4052503, 4052504

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-12

Product code PEN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)