# FDA recall Z-0592-2018

> **Cepheid** · Class II · device recall initiated 2017-10-09.

## Product

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

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

## Key facts

- **Recall number:** Z-0592-2018
- **Recalling firm:** Cepheid
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-09
- **Report date:** 2018-02-21
- **Termination date:** 2018-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0592-2018

## Citation

> AI Analytics. FDA recall Z-0592-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-0592-2018. Source: US FDA. Licensed CC0.

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