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U.S. Department of Health and Human Services

Class 3 Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO

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 Class 3 Recall
MAS Omni IMMUNE and Omni IMMUNE PRO
see related information
Date Posted November 19, 2012
Recall Status1 Terminated on March 04, 2013
Recall Number Z-0379-2013
Recall Event ID 62987
Premarket Notification
510(K) Number
K110616 
Product Classification Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
Product 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. .
Code Information MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
Recalling Firm/
Manufacturer
Microgenics Corporation
44660 Osgood Rd
Fremont, California 94539-6410
For Additional Information Contact Karen Lee
510-979-5000 Ext. 31814
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Microgenics Corporation sent a Recall Notification letter dated August 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed that immediate attention is required and identify the two affected constituents. The letter contains a list of the affected product with their catalog number, lot number and expiration date and request that the CK-MB and Insulin use be discontinued. The remaining components of the product may be used. Evaluate quality controls according to your laboratory procedures. Retain a copy of the letter for your laboratory records. If the product was forwarded to another laboratory, provide them with a copy of the letter. Complete the attached Recall Response form and return within 5 days. Questions may be directed to 1-800-232-3342.
Quantity in Commerce 2076 total in US , 596 total Foreign
Distribution Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = MICROGENICS CORP.
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