Roche Diagnostics Operations, Inc. recalls Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma o…
- Recall date
- October 4, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0679-2020
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US Nationwide distribution in the states of NJ, HI, IA.
Why it was recalled
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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