Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collecti
FDA device recall Z-2432-2015 · posted 2015-08-20 · Terminated
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date.
- Action taken
- Notification letters dated July 28 and 29th to all affected customers via Federal Express..
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- LSL
- Quantity affected
- 1800 kits US, 31 ROW
- Distribution
- Worldwide distribution. US nationwide, including North Mariana Islands, Aruba, Canada, Chile, Colombia, Costa Rica, Cyprus, Guam, Guatemala, Italy, Malawi, Micronesia Federated States, Panama, San Mar
- Date initiated
- 2015-07-27
- Date posted
- 2015-08-20
- Date terminated
- 2015-09-28
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPERT CT/NG (K121710) | Cepheid | 2012-12-27 |