FDA recall Z-1855-2021
Abbott Laboratories Inc. (St Jude Medical) · Class II · device
Product
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Reason for recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Distribution
US Nationwide distribution in the states of MI, KS, MO, TX.
Key facts
- Status
- Terminated
- Initiation date
- 2021-05-05
- Report date
- 2021-06-23
- Termination date
- 2024-06-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Saint Paul, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2021