FDA Device recall Z-2584-2024
Cepheid, Sample Collection Device, Part: 900-0370
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of Cepheid, Sample Collection Device, Part: 900-0370 by Cepheid, citing 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 fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2584-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-20 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cepheid |
| Distribution | US |
Product
Cepheid, Sample Collection Device, Part: 900-0370
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.
Identifiers
| code_info | UDI-DI: 28053326001523. Lot/Expiration: 230397900/ July 3, 2024; 230535300/ July 14, 2024; 230627500/ August 4, 2024; 231877400/ April 10, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2584-2024%22
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