Home / Recalls / Medical Devices
Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit REF 10101018
Recalled December 7, 2022 · FDA recall Z-0345-2023 · Accelerate Diagnostics
Hazard
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp. · FDA Class II
Units
200 kits
Sold at
U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates
Description
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
Product
Accelerate PhenoTest BC kit REF 10101018
Manufacturer(s)
Accelerate Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →