Z-0345-2023 Class II Ongoing
FDA device recall Z-0345-2023 was initiated by Accelerate Diagnostics Inc on October 17, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 200 kits.
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