Z-1293-03

CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test)...

Name: Z-1293-03 CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test)...
Creator: Roche Diagnostics Corp.
Published: 2003-09-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-09-12 / Terminated / root cause: packaging

FDA source

Roche Diagnostics Corp. began a recall of CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48... on 2003-09-12. The reason FDA records is "Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1293-03
Status: Terminated
Initiated: 2003-09-12
Posted: 2003-10-15
Terminated: 2004-05-11
Recalling firm: Roche Diagnostics GmbH
Product: CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].
Product code: GJS Test, Time, Prothrombin
Reason for recall: Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent recall letters dated 9/12/03 were sent to customers of 2 lots on 9/12/03 instructing them to cease using the recalled lots and to inform the attending physician of any patients diagnosed using these lots. Distributors were asked to forward the letter to all customers who had received CoaguChek test strips or system care products. A copy of the recall notification was sent to the entire professional customer list reminding them to always inspect the product for seal integrity. The recall was extended to all lots via 9/26/03 press release. Recall letters were sent to all professional and home users on or about 10/1/03 advising them to inspect the package seal, to run each sample twice (with two test strips). Home users were asked to notify their physician of the problem.
Quantity in commerce: 363628
Distribution: United States, Australia, Austria, Belgium, Chile, Czech Republic, Greece, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland and the United Kingdom.
Product codes and lots: Catalog number 3116247 , Lots 591 and 619; Catalog # 1937642, Lot 600; and Catalog # 1937634, Lot 583. Extended to all lots with an expiration date of on or before March 1, 2005.

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)