Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568 — Class II medical device recall Z-0592-2018
Terminated recall by Cepheid, reported 2018-02-21, distributed in PR. Cepheid has received reports that some of our customers have experienced a higher number of temperature drift
| Recall number | Z-0592-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2017-10-09 |
| Classified | 2018-02-12 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-02-13 |
| Distributed | PR |
| Countries outside the US | HT |
| Lot numbers | 1000049568, 1000053075, 1000056156, 1000056157, 25718, 25719, 25725, 25727 |
| Model numbers | GXCT/NG-10, GXCT/NG-120 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0592-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.