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 | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results. |
| Product | Cepheid, Sample Collection Device, Part: 900-0370 |
| Quantity | 651,150 |
| Distribution | Worldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN, KY, NH, WI, MO, NC, UT, WA, FL, NJ, SC, CO, PA, SD, NE, MT, WV, GA, MA, RI, CT, DE, MS, OK, VA, ID, AZ, OR, MI, IN, TN, AL, KS, ME, AR, NV, HI, AK, NM, WY, VT, ND, DC OUS (foreign) to countries of: Chile, Ireland, Oman, Nicaragua, Germany, San Marino, Ecuador, New Caledonia, France, Austria, United Kingdom, Finland, Ital… |
| Initiated | 2024-06-20 |
| Classified | 2024-08-13 |
| Recall number | Z-2584-2024 |
| 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-2584-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94932/
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