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.
Reported: December 25, 2019 Initiated: October 4, 2019 #Z-0679-2020
Product Description
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.
Reason for Recall
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 82 units (US)
- Distribution
- US Nationwide distribution in the states of NJ, HI, IA.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product 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.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 82 units (US).
Why was this product recalled? ▼
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0679-2020.
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