Microgenics Recalls MAS Omni Immune Controls Due to Labeling Error
Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a documentation error where the package insert was not updated to reflect a formulation change.
Plain-English summary
Microgenics Corporation is recalling 3,185 units of MAS Omni Immune Controls. The recall was initiated because the constituent Inhibin A was removed from the MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls, but the package insert was not updated to reflect this change.
The affected products include part numbers OIM-101, OIM-202, OIM-303, and OIM-SP, with lot numbers OIM15091, OIM15092, OIM15093, and OIM1509S. All lots have an expiration date of 9/30/2015. The products were distributed nationwide in the United States as well as in Australia, China, Germany, Hong Kong, and Malaysia.
Consumers and healthcare providers should stop using the affected products and contact Microgenics Corporation for further instructions.
The recalled product
- Product
- MAS Omni Immune Controls
- Manufacturer
- Microgenics Corporation
- Hazard
- Affected units
- 3,185
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Microgenics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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