Microgenics Recalls MAS Omni Immune PRO Controls Due to Labeling Error
Microgenics Corporation is recalling MAS Omni Immune PRO 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 by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling discrepancy rather than a direct physical hazard.
Plain-English summary
Microgenics Corporation is recalling 1,393 units of MAS Omni Immune PRO 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 were distributed nationwide in the United States and in Australia, China, Germany, Hong Kong, and Malaysia. The specific lots involved are OPR015101, OPR015102, OPR015103, and OPR01510S, all of which have an expiration date of 10/31/2015.
Consumers and healthcare providers should stop using the affected controls and contact Microgenics Corporation for further instructions or a replacement.
The recalled product
- Product
- MAS Omni Immune PRO Controls
- Manufacturer
- Microgenics Corporation
- Hazard
- Affected units
- 1,393
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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