CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Xpert CT/NG recalled by Cepheid
Cepheid is recalling Xpert CT/NG, distributed in Puerto Rico. The recall was initiated on 9 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0592-2018
- FDA event ID
- 78910
- Recalling firm
- Cepheid, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2017
- FDA classified
- 12 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Oct 2017 | Recall initiated by company | |
| 12 Feb 2018 | Classified by FDA | +126 days |
| 21 Feb 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot numbers: 25718, 25719, 25725, and 25727.
Where was it sold?
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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