Z-1358-06

ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model...

Name: Z-1358-06 ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model...
Creator: Roche Diagnostics Corp.
Published: 2006-06-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-06-22 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930 on 2006-06-22. The reason FDA records is "The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1358-06
Status: Terminated
Initiated: 2006-06-22
Posted: 2006-08-05
Terminated: 2008-04-07
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error.
FDA root cause: Other
Action: A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.
Quantity in commerce: 55,189 meters (for all Recalls Z-1354-1371-06)
Distribution: Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Product codes and lots: All units.

Product code CGA

K930979Class IIAccu-Chek Advantage Blood Glucose SystemBoehringer Mannheim Corp. / cleared 1993-09-08

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)