PlainRecalls
FDA Devices Low Class III Terminated

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. .

Reported: November 28, 2012 Initiated: August 20, 2012 #Z-0379-2013

Product Description

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. .

Reason for Recall

In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

Details

Recalling Firm
Microgenics Corporation
Units Affected
2076 total in US , 596 total Foreign
Distribution
Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Location
Fremont, CA

Frequently Asked Questions

What product was recalled? ▼
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. .. Recalled by Microgenics Corporation. Units affected: 2076 total in US , 596 total Foreign.
Why was this product recalled? ▼
In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Low. Recall number: Z-0379-2013.

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