Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
Customers have reported a higher than expected number of invalid test results when using the recalled product per the package insert.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Cepheid to request your refund or repair — edit it as you like.
Subject: Recall Z-0028-2018 — Cepheid Cepheid recalls Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a rever Hello, I own a Cepheid recalls Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction that is covered by recall Z-0028-2018 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.
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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.