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
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- March 7, 2019
- Terminated
- August 24, 2022
- Recall Number
- Z-1133-2019
- Quantity
- 20350
- Firm Location
- Salt Lake City, UT
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.
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
Lot / Code Info
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
Root Cause
Material/Component Contamination
Action Taken
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.