Z-1306-06

Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky...

Name: Z-1306-06 Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky...
Creator: Abbott Diabetes Care, Inc.
Published: 2006-05-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-05-22 / Terminated / root cause: manufacturing process

FDA source

Abbott Diabetes Care, Inc. began a recall of Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics... on 2006-05-22. The reason FDA records is "The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1306-06
Status: Terminated
Initiated: 2006-05-22
Posted: 2006-08-03
Terminated: 2006-12-21
Recalling firm: Abbott Medical
Product: Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
Quantity in commerce: approx. 2,365,000 meters (both recall numbers)
Distribution: Worldwide
Product codes and lots: All codes.

Product code NBW

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)