Z-2478-2019 Class II Terminated
FDA device recall Z-2478-2019 was initiated by Roche Diagnostics Operations, Inc. on July 18, 2019 and is designated Class II. Reason for recall: Quality issue with high pressure solenoid valves The recall status is terminated (terminated June 15, 2020). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- July 18, 2019
- Termination Date
- June 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
cobas c513 Analyzer
Reason for Recall
Quality issue with high pressure solenoid valves
Distribution Pattern
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Code Information
Serial # :1731-08, 1722-03