FDA recall Z-0346-2023

Accelerate Diagnostics Inc · Class II · device

Product

Accelerate PhenoTest BC kit REF 10102018

Reason for recall

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-10-17
Report date: 2022-12-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tucson, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0346-2023