Reported Jun 16, 2021 · Terminated
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS)…
Normand-Info S.A.S.U.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Normand-Info S.A.S.U. · 7 rue Frederic Degeorge · Arras CEDEX, N/A · N/A
Is this the product you have?
- Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
- Lot codes and dates
- Catalog Numbers
B08688B22517B35058B74811
- B92487 UDINone
- Lot NumbersAll Lots
- Catalog Numbers
- Amount recalled
- 8,402 units with the affected software
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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