Z-0715-03

Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and...

Name: Z-0715-03 Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and...
Creator: Roche Diagnostics Corp.
Published: 2003-02-12
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-02-12 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141 on 2003-02-12. The reason FDA records is "Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0715-03
Status: Terminated
Initiated: 2003-02-12
Posted: 2003-04-09
Terminated: 2003-09-15
Recalling firm: Roche Diagnostics GmbH
Product: Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
FDA root cause: Other
Action: Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
Distribution: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
Product codes and lots: All lots.

Product code LFR

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)