Reported Nov 28, 2012 · Terminated
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use…
Microgenics Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microgenics Corporation · 44660 Osgood Rd · Fremont, CA · 94539-6410
Is this the product you have?
- Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014 2 OIM-202 - OIM14032 - 31 MAR 2014 3 OIM-303 - OIM14033 - 31 MAR 2014 4 OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014 5 OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014 6 OPRO-SP - OPRO1403S - 31 MAR 2014. - Amount recalled
- 2076 total in US , 596 total Foreign
Where it was sold
- Nationwide
Why it was recalled
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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