Class II — Cepheid
| Recalling firm | CEPHEID |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only |
| Quantity | 89,958 kits ( 10 test per kit) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Costa Rica, Ireland, Estonia, United Kingdom, Germany, Italy, Greece, Poland, Switzerland, Hong Kong, United Arab Emirates. |
| Initiated | 2023-04-24 |
| Classified | 2023-11-02 |
| Recall number | Z-0215-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cepheid (Z-0215-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93125/
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