Z-0994-2011

Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips

Name: Z-0994-2011 Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
Creator: Abbott Diabetes Care, Inc.
Published: 2010-12-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-12-22 / Terminated / root cause: manufacturing process

FDA source

Abbott Diabetes Care, Inc. began a recall of Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips on 2010-12-22. The reason FDA records is "Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results". 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-0994-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-02-09
Terminated: 2011-10-25
Recalling firm: Abbott Medical
Product: Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.
Quantity in commerce: 359 total lots of 1,000,000 strips each.
Distribution: Products were released for distribution in US and Puerto Rico.
Product codes and lots: Lot codes: 44535H, 44545H, 44565H, 445A5H, 44645H, 44665H, 446E5H, 44725H, 44755H, 44925H, 44945H, 44945H, 44975H, 44995H, 449A5H, 44A15H, 44A35H, 44A75H, 44A85H, 44C65H, 44C75H, 44CE5H, 44CH5H, 44CP5H, 44CR5H, 45025H, 45035H, 450A5H, 450C5H

Product code NBW

K070984Class IIThe Precision / Optium Point of Care Blood Glucose Test StripsAbbott Diabetes Care, Inc. / cleared 2007-11-01

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)