Z-0227-2007

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12...

Name: Z-0227-2007 CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12...
Creator: Roche Diagnostics Corp.
Published: 2006-10-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-10-18 / 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), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog... on 2006-10-18. The reason FDA records is "Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0227-2007
Status: Terminated
Initiated: 2006-10-18
Posted: 2006-11-30
Terminated: 2007-06-20
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].
Product code: GJS Test, Time, Prothrombin
Reason for recall: Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
FDA root cause: Other
Action: A press release was issued by the firm on 10/19/06. The recall letter dated 10/19/06 sent to distributors who sell to home users instructs them to notify their home users and to discard any of product 3116239 in stock. The recall letter dated 10/19/06 to to home users, instructs them to discontinue use of, and to discard, their test strips and to contact their health care professional. The device correction letter dated 10/19/06 to distributors to professional users instructs them to notify customers and provides instructions for duplicate testing in laboratories. The device correction letter dated 10/19/06 to health care professionals asks that they follow-up with their home users to ensure they follow the instructions to cease home use and provides instructions for dupicate testing in laboratories.
Quantity in commerce: Approx 26,000,000 test strips to U.S. and 31,000,000 test strips Ex-U.S.
Distribution: Worldwide
Product codes and lots: All lots.

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)