Accelerate Diagnostics Inc Recall 91075
Description: Accelerate PhenoTest BC kit REF 10101018
Accelerate Diagnostics Inc Recall 91075 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0345-2023 |
| Event ID | 91075 |
| Event Description | Accelerate PhenoTest BC kit REF 10101018 |
| Product Type | Devices |
| 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 |
| Quantity | 200 kits |
| Recall Reason | 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. |
| Device Classification | 20221207 |
| Device Code Info | Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A |
| Center Classification Date | 20221130 |
| Recall Initiation Date | 20221017 |
| Recalling Firm | Accelerate Diagnostics Inc |
| Initial Notification | Other |
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