Recall Z-0379-2013 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Microgenics Corporation
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 instrum
| Date | Nov 19, 2012 (initiated Aug 20, 2012) |
| Status | Terminated |
| Reason | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. |
| Root cause | 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 proce |
| Quantity | 2076 total in US , 596 total Foreign |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO Microgenics Corp., Jun 29, 2011 |