Practical implication
Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.
Microgenics Corporation has initiated an urgent corrective safety action concerning the MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control due to reported variability between vials leading to low recovery of parathyroid hormone (PTH) for specific lots. Users receiving this notification must respond within 10 days and assess their inventory for affected products.
What changed: An urgent safety action (FSCA) has been implemented requiring affected users to fill out an acknowledgment form within 10 days.
Why it matters: The variability may cause delays in patient results, although serious health consequences are deemed unlikely. Prompt user response is crucial to ensure patient safety and accurate diagnostics.
Practical implication: Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.
View original source
- Source: ANSM (France) - Safety information feed
- Published at source: 2026-09-03T00:00:00.000Z
- Discovered by monitor: 2026-09-03T21:47:55.801Z
Published from the regulator source ingestion pipeline after PV impact triage.
