FDAOctober 18, 2018device
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
What to do
FDA enforcement status: Terminated
Brands named
eurotrol
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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