Z-0047-06

RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop...

Name: Z-0047-06 RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop...
Creator: Abbott Laboratories Medisense Products
Published: 2005-06-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-06-07 / Terminated

FDA source

Abbott Laboratories Medisense Products began a recall of RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502 on 2005-06-07. The reason FDA records is "User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0047-06
Status: Terminated
Initiated: 2005-06-07
Posted: 2005-10-21
Terminated: 2006-05-17
Recalling firm: Abbott Medical
Product: RiteAid Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
FDA root cause: Other
Action: The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.
Distribution: Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
Product codes and lots: All lot numbers are included in this recall.

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)