Z-1133-2019 Class II Terminated
FDA device recall Z-1133-2019 was initiated by BioFire Diagnostics, LLC on March 7, 2019 and is designated Class II. 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. The recall status is terminated (terminated August 24, 2022). Affected quantity: 20350.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- March 7, 2019
- Termination Date
- August 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20350
Product Description
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
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 Pattern
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
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