PV Bulletin

MAS Omni Immune Pro Reagent – Microgenics Corporation, Thermo Fisher Scientific

Urgent safety notice issued by Thermo Fisher Scientific regarding product variability in MAS Omni Immune Pro reagent.

Primary source: Téléchargez le courrier de la société Thermo Fisher Scientific (03/09/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 3, 2026

Full briefing

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.

#Translated From French#Safety Signals#France#Ansm.sante.fr#Safety Signal#Source-ingestion#Regulator-monitor

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