Z-0814-03

CoaguChek Plus meter; catalog # 475729 and 12816001

Name: Z-0814-03 CoaguChek Plus meter; catalog # 475729 and 12816001
Creator: Roche Diagnostics Corp.
Published: 2003-03-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-03-12 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of CoaguChek Plus meter; catalog # 475729 and 12816001 on 2003-03-12. The reason FDA records is "High frequency signals from other medical or communications equipment will result in a variable positive bias in test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0814-03
Status: Terminated
Initiated: 2003-03-12
Posted: 2003-05-14
Terminated: 2005-02-03
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek Plus meter; catalog # 475729 and 12816001.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
FDA root cause: Other
Action: Urgent Product Removal letters dated 3/12/03 were sent to all customers. Distributors were asked to conduct a recall from their customers. Replacement meters are not currently available from Roche. Roche will temporarily provide a CoaguChek S system to run PT samples and will reimburse for APTT and ACT tests that are sent to an accredited outside laboratory.
Quantity in commerce: 472
Distribution: United States
Product codes and lots: All units

Product code JPA

K860719Class IIBiotrack Protime Controls (Biotrack Protime Test)Biotrack, Inc. / cleared 1986-05-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)