FDAJuly 25, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
What to do
FDA enforcement status: Terminated
Brands named
microgenics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAThermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtaine...2016-08-15
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