FDA-Device2022-12-07Class II
Accelerate PhenoTest BC kit REF 10102018
Accelerate Diagnostics Inc
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.
Sold states
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
Affected count
7,160 kits
Manufactured in
3950 S Country Club Rd Ste 470, Tucson, AZ, United States
Products
Accelerate PhenoTest BC kit REF 10102018
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0346-2023Don't want to check this manually?
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