FDA Recall 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. .

Recall: Z-0379-2013 · Initiated August 20, 2012

Recall

Recall Number: Z-0379-2013
Event Number: 62987
Firm: Microgenics Corporation
FEI Number: 3010939897
Product Code: JJY
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: August 20, 2012
Posted: November 19, 2012
Terminated: March 4, 2013
Address: 44660 Osgood Rd, Fremont, CA, 94539-6410

Description

Reason

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

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.

Distribution

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

Quantity

2076 total in US , 596 total Foreign