Microgenics Recalls DRI Salicylate Serum Tox Assay Due to Sensitivity Issues
Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the issue is a performance deviation (sensitivity claim) rather than a direct physical hazard like a structural defect or contamination.
Plain-English summary
Microgenics Corporation is recalling 1,708 kits of the DRI Salicylate Serum Tox Assay, Catalog number 0977. This product is intended for the quantitative determination of salicylate in human serum or plasma. The recall affects specific lots with expiration dates ranging from December 2016 to October 2018.
The recall was initiated because some lots of the assay's negative patient samples are recovering higher than the product's stated sensitivity claim of 4.4 mg/dL. This discrepancy may affect the accuracy of the test results.
The affected products were distributed worldwide, including nationwide in the United States to Arizona, California, Missouri, Texas, and Puerto Rico, as well as to Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan. Users of the product should contact Microgenics Corporation for further instructions on how to proceed.
The recalled product
- Product
- DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
- Manufacturer
- Microgenics Corporation
- Affected units
- 1,708
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 (4)
- Lot Number Expiration Date 60704602 DEC 2016
- 72035410 JUL 2017
- 72208738 FEB 2018
- 72409454 OCT 2018.
Distribution
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