Roche Coaguchex XS Systems for Patient Self-Testing, Roche… recallZ-1594-2009 · Roche Diagnostics Corp. · initiated May 13, 2009
Terminated All recalls posted in August 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1594-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 13, 2009
- Posted by the FDA
- Aug 11, 2009
- Recalling firm
- Roche Diagnostics Corp.
- Quantity
- 449,533 packages of lancets
- Product code
- GJS
- FDA submissions
- K062925
- Distribution
- Nationwide.
Product description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
3 devices cleared under K062925 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COAGUCHEK XS PT TEST 6 STRIP 4625374160Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN3 deaths1,681 reports
- CoaguChek XS Patient Self Testing Care Kit 03666794001Roche Diagnostics GmbH · Test, Time, Prothrombin212 reports
- CoaguChek XS Patient Self Testing Care Kit 4837738001Roche Diagnostics GmbH · TEST, TIME, PROTHROMBIN134 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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