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Roche Diagnostics Operations, Inc. recalls Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on
Recalled December 25, 2019 · FDA recall Z-0679-2020 · Roche Diagnostics Operations
Hazard
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules · FDA Class II
Units
82 units (US)
Sold at
US Nationwide distribution in the states of NJ, HI, IA.
Description
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Product
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →