Z-0679-2020 Class II Terminated
FDA device recall Z-0679-2020 was initiated by Roche Diagnostics Operations, Inc. on October 4, 2019 and is designated Class II. Reason for recall: Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules The recall status is terminated (terminated October 9, 2020). Affected quantity: 82 units (US).
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- October 4, 2019
- Termination Date
- October 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82 units (US)
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
Distribution Pattern
US Nationwide distribution in the states of NJ, HI, IA.
Code Information
Lot Number: 422313 Exp Date: 07/31/2020