medical Class II Updated 2019-12-25

Roche Diagnostics Operations, Inc. recalls Roche Homocysteine-In vitro test for the quantitative determ

Recalled 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.

Hazard / Issue

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 422313 Exp Date: 07/31/2020
View official government recall

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