CLASS II Device recall · Reported 23 Jun 2021 · FDA Enforcement Report
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate recalled
Abbott Laboratories Inc. (St Jude Medical) is recalling v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, distributed nationwide in the US. The recall was initiated on 5 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1853-2021
- FDA event ID
- 87904
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2021
- FDA classified
- 14 Jun 2021
- Reported
- 23 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 5 May 2021 | Recall initiated by company | |
| 14 Jun 2021 | Classified by FDA | +40 days |
| 23 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
Where it was distributed
US Nationwide distribution in the states of MI, KS, MO, TX.
Questions about this recall
Why was it recalled?
Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Which lots are affected?
Serial Numbers: 14399319, 15508962, 18782712, 18855856
Where was it sold?
US Nationwide distribution in the states of MI, KS, MO, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87904This product is part of a recall event; the main page for the event is v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate recalled | Abbott Laboratories Inc. (St Jude Medical) | Device Malfunction | Nationwide | |
| CLASS II | WorkMate Claris v.1.2 Upgrade Kits recalled | Abbott Laboratories Inc. (St Jude Medical) | Device Malfunction | Nationwide |
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