FDAFDA · Food and drugs·Recall number Z-1133-2019
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
Published April 24, 2019 · Recall initiated: March 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- 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
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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