Normand recalls software devices that interface lab systems and instruments. Incorrectly programmed rules may cause erroneous lab results. Affected units have catalog numbers B08688, B2:22517, B35058, B74811, B92487.
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.
Normand is recalling its Remisol Advance Data Manager software devices because outdated instructions could lead to incorrectly programmed rules that cause lab results to be wrong. This affects laboratory information systems that interface with lab instruments.
The software versions 1.5 to 1.9 had insufficient instructions for programming and testing rules. This means users might create rules that aren't properly validated, leading to incorrect lab results.
Laboratories using the software device for lab information systems are affected. Users with the catalog numbers B08688, B22517, B35058, B74811, or B92487 are most at risk.
Check if your software device has catalog numbers B08688, B22517, B35058, B74811, or B92487. The product interfaces lab information systems with laboratory instruments.
Verify your software version is 1.5 to 1.9 to determine if it's affected.
Software versions 1.5 to 1.9.
Check for catalog numbers B08688, B22517, B35058, B74811, or B92487.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Normand to request your refund or repair — edit it as you like.
Subject: Recall Z-1831-2021 — Normand Normand Hello, I own a Normand that is covered by recall Z-1831-2021 from Normand. 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.
