Cepheid recalls specific batches of Xpert CT/NG test kits due to higher temperature drift errors and occasional false negative results. Affected kits may not detect infections accurately.
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.
Cepheid is recalling certain batches of Xpert CT/NG test kits because they may show higher temperature drift errors and occasionally produce false negative results. This could lead to missed infections if the test is used incorrectly.
The test kits may experience temperature drift errors, causing inconsistent results. This can lead to occasional false negative results, meaning infections might not be detected when they should be.
Healthcare professionals using Cepheid Xpert CT/NG test kits for infection testing are most at risk if they use the recalled batches. Patients relying on these tests for accurate results may also be affected.
Check the batch numbers: 1000049568, 1000053075, 1000056156, and 1000056157. The kits are labeled as Xpert CT/NG Catalog GXCT/NG-120 or GXCT/NG-10.
Look for batch numbers 1000049568, 1000053075, 1000056156, or 1000056157 on the test kit packaging.
Cepheid has received reports of higher temperature drift errors and occasional false negative results in some batches of these test kits.
Check the batch numbers on the packaging. If you have the recalled batch numbers, contact Cepheid for guidance.
The recall is for potential false negative results, which could miss infections. There is no mention of physical harm or injury in the recall notice.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0592-2018 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0592-2018 from Cepheid. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
