Z-1853-2021Class II

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris"...

Name: Z-1853-2021 v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris"...
Creator: Abbott Laboratories Inc. (St Jude Medical)
Published: 2021-05-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-05-05 / Terminated / root cause: software

FDA source

Abbott Laboratories Inc. (St Jude Medical) began a recall of 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... on 2021-05-05. FDA classified it as Class II and gives the reason as "Due to a software error, the user may lose functionality of the system or the screen may turn black during operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1853-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-05
Posted: 2021-06-14
Terminated: 2024-06-18
Recalling firm: Abbott Medical
Product: 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.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: 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.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of MI, KS, MO, TX.
Product codes and lots: Serial Numbers: 14399319, 15508962, 18782712, 18855856

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1853-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1853-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-14
Z-1854-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-14
Z-1855-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-14

Product code DQK

K210392Class IIWorkMate Claris SystemAbbott / cleared 2021-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)