Recall Z-1855-2021— Abbott Laboratories Inc. (St Jude Medical)
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories Inc. (St Jude Medical), initiated 2021-05-05, terminated 2024-06-18. It names one FDA 510(k) clearance: K210392. Product: WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012. Reason: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation..
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-05
- Terminated
- 2024-06-18
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.