FDA Device recall Z-1855-2021
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
- FDA Device
- Class II
- terminated
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 by Abbott Laboratories St Jude Medical, citing due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1855-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-05 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Laboratories St Jude Medical |
| Distribution | US |
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.
Identifiers
| code_info | None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1855-2021%22
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