Z-0592-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- October 9, 2017
- Termination Date
- February 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,586 kits (49,400 units)
Product Description
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.
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 Pattern
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Code Information
Lot numbers: 25718, 25719, 25725, and 25727.