Z-1363-06

ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos...

Name: Z-1363-06 ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos...
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 Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and... 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 bad strip". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1363-06
Status: Terminated
Initiated: 2006-06-22
Posted: 2006-08-05
Terminated: 2008-04-07
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no. 250.
Product code: LFR Glucose Dehydrogenase, 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 bad strip.
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 LFR

K973662Class IIAccu-Chek(r)complete System/meter & Accu-Chek Advantage Test Strips/accu-Chek Advantage H Test StripsBoehringer Mannheim Corp. / cleared 1997-12-15

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)