FDA Device recall Z-0345-2023
Accelerate PhenoTest BC kit REF 10101018
- FDA Device
- Class II
- ongoing
- Published 2022-12-07
On 2022-12-07 the FDA classified a Class II recall of Accelerate PhenoTest BC kit REF 10101018 by Accelerate Diagnostics, citing due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0345-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-17 |
| Published | 2022-12-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Accelerate Diagnostics |
| Distribution | 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, WV |
Product
Accelerate PhenoTest BC kit REF 10101018
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.
Identifiers
| code_info | Part Number: 10101018 UDI-DI Code: 00862011000307 Lot Numbers: 5549A 5566A 5588A 5606A 5612A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0345-2023%22
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