Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use a

FDA device recall Z-0379-2013 · posted 2012-11-19 · Terminated

Recall details

Recalling firm

Microgenics Corporation

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJY

Quantity affected

2076 total in US , 596 total Foreign

Distribution

Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.

Date initiated

2012-08-20

Date posted

2012-11-19

Date terminated

2013-03-04

Location

Fremont, CA

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