Device 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.
Z-0679-2020
Product summary
- Event
- Event 84018
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 units (US)
- Official record key
device-enforcement:Z-0679-2020
Official wording
Reason: Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Code information: Lot Number: 422313 Exp Date: 07/31/2020
Distribution pattern: US Nationwide distribution in the states of NJ, HI, IA.
Derived failure modes
-
Unknown
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules