FDA recall Z-2476-2019
Roche Diagnostics Operations, Inc. · Class II · device
Product
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Reason for recall
Quality issue with high pressure solenoid valves may cause inaccurate results.
Distribution
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Key facts
- Status
- Terminated
- Initiation date
- 2019-07-18
- Report date
- 2019-09-11
- Termination date
- 2020-06-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Indianapolis, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2476-2019