Z-1381-06

Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001...

Name: Z-1381-06 Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001...
Creator: Roche Diagnostics Corp.
Published: 2006-06-27
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-06-27 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003 on 2006-06-27. The reason FDA records is "The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1381-06
Status: Terminated
Initiated: 2006-06-27
Posted: 2006-08-11
Terminated: 2007-05-04
Recalling firm: Roche Diagnostics GmbH
Product: Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose results
FDA root cause: Other
Action: U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified.
Quantity in commerce: 21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls Z-1377-1384-06)
Distribution: Worldwide Distribution-USA and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Paraguay, Peru, Philippines, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand and Uruguay.
Product codes and lots: All lots expiring before July 31, 2007.

Product code LFR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)