Z-0566-06

Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001...

Name: Z-0566-06 Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001...
Creator: Roche Diagnostics Corp.
Published: 2006-02-10
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-02-10 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and... on 2006-02-10. The reason FDA records is "There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation 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-0566-06
Status: Terminated
Initiated: 2006-02-10
Posted: 2006-02-28
Terminated: 2007-02-08
Recalling firm: Roche Diagnostics GmbH
Product: Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States).
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
FDA root cause: Other
Action: Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.
Distribution: Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
Product codes and lots: All lots.

Product code LFR

K010362Class IIAccu-Chek Comfort Curve Test StripRoche Diagnostics Corp. / cleared 2001-03-07

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)