Official recall notice

FDA DeviceClass IINotable

FDA Recall: REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL A

Recall date
2026-08-12
FDA class
Class II

Why it was recalled

Hazard

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Product description

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Affected products

Software Version 2.5 UDI-DI code: 15099590802073

Verify with the official notice →
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