Thermo Scientific MAS Bilirubin Recalled for Reduced Stability
Microgenics Corporation is recalling Thermo Scientific MAS Bilirubin test samples because in-house testing confirmed reduced stability of Direct and Total Bilirubin.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves reduced stability of a laboratory control sample without reported patient injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Microgenics Corporation is recalling 188 units of Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems. The product is a test sample intended for monitoring assay conditions in clinical laboratories.
The recall was initiated after in-house testing confirmed that Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) in the product are displaying reduced stability. The affected units are identified by Catalog Number 10014432 and Lot Numbers 1MQ310, 2CQ310, and 2KQ310.
The product was distributed nationwide in the United States, including the states of Wisconsin, Utah, Florida, New York, Pennsylvania, Illinois, Colorado, Arizona, and New Jersey. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in m
- Manufacturer
- Microgenics Corporation
- Hazard
- Affected units
- 188
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog Number: 10014432
- Lot Numbers: 1MQ310
- Expiration Date: 31 Dec 2013
- 2CQ310
- Expiration Date: 31 Mar 2014
- 2KQ310
- Expiration Date: 31 Oct 2014
Distribution
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