Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
- Company
- Cepheid
- Recall Initiated
- November 17, 2011
- Posted
- January 11, 2012
- Terminated
- January 9, 2012
- Recall Number
- Z-0453-2012
- Quantity
- 1289
- Firm Location
- Sunnyvale, CA
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.
Distribution
Product was released for distribution in US.
Lot / Code Info
Lots affected: 2803 and 3001
Root Cause
Nonconforming Material/Component
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.
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