Cepheid: Medical Device Recall in 2018 - (Recall #: Z-0592-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 9, 2017

Date Posted: February 21, 2018

Recall Number: Z-0592-2018

Event ID: 78910

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.

Status: Terminated

Product Quantity: 3,586 kits (49,400 units)

Code Information:

Lot numbers: 25718, 25719, 25725, and 25727.

Distribution Pattern:

Worldwide Distribution -- USA, Puerto Rico, and Haiti.

Voluntary or Mandated:

Voluntary: Firm initiated