Z-0737-2007

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use)

Name: Z-0737-2007 CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use)
Creator: Roche Diagnostics Corp.
Published: 2007-02-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-02-28 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use) on 2007-02-28. The reason FDA records is "The product was erroneously distributed to home users in contrast to its use for healthcare professionals only". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0737-2007
Status: Terminated
Initiated: 2007-02-28
Posted: 2007-04-11
Terminated: 2007-06-13
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
Product code: GJS Test, Time, Prothrombin
Reason for recall: The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
FDA root cause: Other
Action: All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
Quantity in commerce: 10
Distribution: Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
Product codes and lots: Lots 469A and 475A; exp. 6/30/2008.

Product code GJS

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)