Z-0720-03

CoaguChek PT test strips, sold in 12 pack

Name: Z-0720-03 CoaguChek PT test strips, sold in 12 pack
Creator: Roche Diagnostics Corp.
Published: 2003-02-20
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-02-20 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of CoaguChek PT test strips, sold in 12 pack on 2003-02-20. The reason FDA records is "Discrepancy between INR and the % Quick displayed on the meter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0720-03
Status: Terminated
Initiated: 2003-02-20
Posted: 2003-04-10
Terminated: 2003-11-10
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek PT test strips, sold in 12 pack.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Discrepancy between INR and the % Quick displayed on the meter.
FDA root cause: Other
Action: Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
Quantity in commerce: 11412 containers
Distribution: Germany
Product codes and lots: lot 533

Product code JPA

K974569Class IICoaguchek System, Coaguchek System for Prothrombin Time Self TestingBoehringer Mannheim Corp. / cleared 1998-01-09

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)