Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568 Recalled by Cepheid Due to Cepheid has received reports that some of our...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.
Affected Products
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.
Quantity: 3,586 kits (49,400 units)
Why Was This 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.
Where Was This Sold?
Worldwide Distribution -- USA, Puerto Rico, and Haiti.
About Cepheid
Cepheid has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report