Recall Z-0379-2013— Microgenics Corporation
Class III · Terminated
Class III FDA medical device recall by Microgenics Corporation, initiated 2012-08-20, terminated 2013-03-04. It names one FDA 510(k) clearance: K110616. 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. .. Reason: In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability..
- Recalling firm
- Microgenics Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-08-20
- Terminated
- 2013-03-04
- Firm location
- Fremont, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.