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U.S. Department of Health and Human Services

Class 2 Device Recall FilmArray BCID Panel

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 Class 2 Device Recall FilmArray BCID Panelsee related information
Date Initiated by FirmMarch 07, 2019
Create DateApril 12, 2019
Recall Status1 Terminated 3 on August 24, 2022
Recall NumberZ-1133-2019
Recall Event ID 82354
510(K)NumberK130914 K143171 K160457 K181493 
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
ProductFilmArray 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
Code Information 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
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
800-735-6544
Manufacturer 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.
FDA Determined
Cause 2		Material/Component Contamination
ActionOn 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 Commerce20350
DistributionMA, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PEN
510(K)s with Product Code = PEN
510(K)s with Product Code = PEN
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