Home / Recalls / Accelerate Diagnostics Inc / Z-0345-2023

Z-0345-2023 Class II Ongoing

Recalled by Accelerate Diagnostics Inc — Tucson, AZ

Recall Details

Product Type: Devices
Report Date: December 7, 2022
Initiation Date: October 17, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 200 kits

Product Description

Accelerate PhenoTest BC kit REF 10101018

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 Pattern

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

Code Information

Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A