Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions
Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as Class II. No deaths, injuries, or illnesses have been reported. The hazard is theoretical—users may write improperly validated rules that could produce erroneous laboratory results, but no actual harm has been documented. Per the rubric, theoretical harm in risk-of-harm products without reported injury scores at most 3 (High).
Plain-English summary
Normand Remisol Advance Data Manager is a software device that connects laboratory information systems (LIS) to laboratory instruments for data management and communication. The recall affects software versions 1.5 through 1.9. Approximately 8,402 units with the affected software have been distributed worldwide, including across the United States and in numerous international markets.
The Instructions for Use for versions 1.5 to 1.9 did not provide sufficient guidance on properly programming and testing the rules that control data processing. This means users may have written rules that were not properly validated or were incorrectly validated, which could result in erroneous laboratory findings.
Laboratories using affected versions should contact Normand-Info S.A.S.U. or their authorized distributor for updated instructions and guidance on validating their rule configurations.
The recalled product
- Product
- Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
- Manufacturer
- Normand-Info S.A.S.U.
- Affected units
- 8,402
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog Numbers: B08688
- B22517
- B35058
- B74811
- B92487 UDI: None Lot Numbers: All Lots
Distribution
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