Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected:
FDA device recall Z-0453-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
- Action taken
- On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NQX
- Quantity affected
- 1289
- Distribution
- Product was released for distribution in US.
- Date initiated
- 2011-11-17
- Date posted
- 2012-01-11
- Date terminated
- 2012-01-09
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 (K101879) | Cepheid | 2010-07-28 |
| XPERT MRSA/SA BLOOD CULTURE ASSAY (K082140) | Cepheid | 2008-09-29 |