Cepheid recalls Xpert SA Nasal Complete kits with catalog number GXSACOMP-10 and UDI-DI code 07332940000158 due to false negative results in post-market testing. Affected kits may not detect MRSA/MSSA bacteria correctly.
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Cepheid is recalling Xpert SA Nasal Complete kits that may give false negative results when testing for MRSA or MSSA bacteria. This means the test might incorrectly show no bacteria when bacteria are actually present, potentially leading to missed infections.
The test kit may produce false negative results during post-market stability testing, meaning it could fail to detect MRSA or MSSA bacteria when they are actually present. This could lead to missed infections if the test is used on clinical specimens.
Healthcare professionals using the Xpert SA Nasal Complete kit for MRSA/MSSA testing are most at risk. Patients receiving these tests may not get accurate results if the kit is defective.
Check for catalog number GXSACOMP-10 and UDI-DI code 07332940000158 on the kit. Lot numbers 27815 or 27816 with batch numbers 1001424179 or 1001424181 are affected.
Verify the catalog number, UDI-DI code, lot numbers, and batch numbers to confirm if the kit is affected.
The recall is due to false negative test results observed in post-market stability testing, which could mean the kit fails to detect MRSA or MSSA bacteria when they are present.
Check the kit details to see if it matches the affected catalog number, UDI-DI code, lot numbers, and batch numbers. If it does, contact Cepheid for further instructions.
This is a low-risk issue as it affects test accuracy rather than physical safety. The kit does not pose a risk of injury or damage.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0414-2026 — Cepheid Cepheid Hello, I own a Cepheid that is covered by recall Z-0414-2026 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.
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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.
