FDA Device recall Z-1529-2018
Accelerate PhenoTest BC kit, Ref #10101018
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Accelerate PhenoTest BC kit, Ref #10101018 by Accelerate Diagnostics, citing the kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1529-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-14 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accelerate Diagnostics |
| Distribution | CA, DE, IL, SC, TX |
Product
Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.
Reason
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Identifiers
| code_info | Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1529-2018%22
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