FDA Enforcement
Class II
Terminated
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.
Recall: Z-0679-2020
·
Reported December 25, 2019
Enforcement
- Recall Number
- Z-0679-2020
- Event ID
- 84018
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2019
- Initiation Date
- October 4, 2019
- Classification Date
- December 13, 2019
- Termination Date
- October 9, 2020
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
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
Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
Code Info
Lot Number: 422313 Exp Date: 07/31/2020
Distribution
US Nationwide distribution in the states of NJ, HI, IA.
Quantity
82 units (US)