FDA Device recall Z-0216-2024
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD
- FDA Device
- Class II
- ongoing
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD by Cepheid, citing pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0216-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-24 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cepheid |
| Distribution | US |
Product
Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
Reason
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
Identifiers
| code_info | UDI: (01)07332940006297/ Lot: 23815 |
|---|
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-0216-2024%22
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