Abbott Laboratories Inc. (St Jude Medical) WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Brand
Abbott Laboratories Inc. (St Jude Medical)
Lot Codes / Batch Numbers
None
Products Sold
None
Abbott Laboratories Inc. (St Jude Medical) is recalling WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 due to Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Recommended Action
Per FDA guidance
Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026