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.
Other recalls by Cepheid
- Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Device · Class II · 2025-12-24 · Cepheid - Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Device · Class II · 2025-12-24 · Cepheid - Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10
FDA Device · Class II · 2025-12-03 · Cepheid - Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit
FDA Device · Class II · 2025-11-05 · Cepheid - Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Device · Class II · 2023-11-08 · Cepheid
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2584-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.