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Microgenics recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1…

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the hazard?

Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.

What's affected

MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP

Read the official FDA Enforcement Report ↗