Z-1594-2009

Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001...

Name: Z-1594-2009 Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001...
Creator: Roche Diagnostics Corp.
Published: 2009-05-13
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2009-05-13 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device... on 2009-05-13. The reason FDA records is "The lancet cap may be missing, which could result in an unintended lancet stick to the user". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1594-2009
Status: Terminated
Initiated: 2009-05-13
Posted: 2009-08-11
Terminated: 2011-01-05
Recalling firm: Roche Diagnostics GmbH
Product: Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
Product code: GJS Test, Time, Prothrombin
Reason for recall: The lancet cap may be missing, which could result in an unintended lancet stick to the user.
FDA root cause: Other
Action: An "Urgent Medical Device Correction" letter dated May 13, 2009 was sent to all affected customers, distributors and consumer consignees who have either registered their blood glucose meter, contacted the firm about the lancets since 10/1/08, or have been shipped lancets by Roche since 10/1/08 were notified of the problem. Distributors were requested to notify each patient self-tester to whom a meter kit was distributed since October 1, 2008. The firm issued a press release on May 18, 2009. Diabetes Care customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7057. CoaguChek meter customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7505.
Quantity in commerce: 449,533 packages of lancets
Distribution: Nationwide.
Product codes and lots: REF 04837738001; 117200, 117202, 117203, 117204, 117205, 117208, 117209, 117213, 117216, 117219, 117220, 117222, 117227, 117228, 117229, 117231, 117233, 117235, 117237, 117238, 117240 and 117241. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.

Product code GJS

K062925Class IICoaguchek Xs SystemRoche Diagnostics Corp. / cleared 2007-01-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)