Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
- Company
- Cepheid
- Recall Initiated
- October 9, 2017
- Terminated
- February 13, 2018
- Recall Number
- Z-0592-2018
- Quantity
- 3,586 kits (49,400 units)
- Firm Location
- Sunnyvale, CA
Reason for Recall
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
Distribution
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Lot / Code Info
Lot numbers: 25718, 25719, 25725, and 25727.
Root Cause
Equipment maintenance
Action Taken
An Urgent Medical Device Recall letter (response form included), dated October 9, 2017, was sent to affected consignees. The letter identified the affected product, the issue involved, impact, and actions to be taken. Cepheid will provide replacement product for Xpert CT/NG assay product identified in this recall. Customers are to complete and the return the Response Form provided in order to receive replacement product. Additionally, the letter instructs users to review their laboratory statistics to see if their positivity rates are trending low during use of the affected lots. If so, they are to review the negative patient results according to their laboratory's Quality Management System. Customers are to refer to the applicable contact information provided if there are any questions.