The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
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 PerkinElmer Life and Analytical Sciences, Wallac, OY to request your refund or repair — edit it as you like.
Subject: Recall Z-1220-2018 — PerkinElmer Life and Analytical Sciences, Wallac, OY PerkinElmer Life and Analytical Sciences, Wall Hello, I own a PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human that is covered by recall Z-1220-2018 from PerkinElmer Life and Analytical Sciences, Wallac, OY. 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.
