FDA Device

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;

Hazard

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.

What You Should Do

Remedy

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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Products

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;
Brand
Cepheid
UPC
Lots affected: 2803 and 3001

Units Affected

1289

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