Class 3 Device Recall Cepheid Xpert MRSA/S Blood Culture

• Date Initiated by Firm: November 17, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on January 09, 2012
• Recall Number: Z-0453-2012
• Recall Event ID: 60481
• 510(K)Number: K082140 K101879
• Product Classification: in vitro diagnostic MRSA - Product Code NQX
• Product: 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
• Code Information: Lots affected: 2803 and 3001
• FEI Number: 3004530258
• Recalling Firm/ Manufacturer: Cepheid; 904 E Caribbean Dr; Sunnyvale CA 94089-1189
• For Additional Information Contact: Judith A Howard; 408-541-4191
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Quantity in Commerce: 1289
• Distribution: Product was released for distribution in US.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NQX