Z-1813-2008

Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring...

Name: Z-1813-2008 Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring...
Creator: Abbott Diabetes Care, Inc.
Published: 2008-04-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-04-24 / Terminated / root cause: manufacturing process

FDA source

Abbott Diabetes Care, Inc. began a recall of Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter on 2008-04-24. The reason FDA records is "Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay...". 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-1813-2008
Status: Terminated
Initiated: 2008-04-24
Posted: 2008-09-11
Terminated: 2011-03-29
Recalling firm: Abbott Medical
Product: Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall initiated on April 24, 2008. An Urgent Medical Device Correction was issued to customers. Consignees were notified, along with registered users of the FreeStyle Freedom meters, via recall letters, visits or phone calls. Distributors will be notified, along with the creation of customer lists and tracking of communications to sub-recall. If you have any questions call Tina Mazurkiewicz at 1-800-777-6565.
Quantity in commerce: 2954900 strips
Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of Sweden, Norway, Netherlands, Luxembourg, Switzerland, Israel and Denmark.
Product codes and lots: Part numbers/Serial numbers/Exp. Date: CAT12050-01/0618625/Jul08; M70449-03/0703325/Feb09; CAT12450-01 (70345-02)/0618129/Jun08; CAT70450-01/0700815/Jan09; CAT70447-02/0628646/Oct08; CAT12450-01 (70345-02)/0627030/Sep08; CAT70450-02/0703019/Jan09; CAT12050-02/0703118/Jan09; CAT12050-03/0715129/May09

Product code LFR

K992684Class IIFreestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. / cleared 2000-01-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)