FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
- Recall number
- Z-0994-2011
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
- Status
- Terminated
- Initiated
- 2010-12-22
- Posted
- 2011-02-09
- Terminated
- 2011-10-25
- Reason
- 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
- 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
- 359 total lots of 1,000,000 strips each.
- Distribution
- Products were released for distribution in US and Puerto Rico.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K070984"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3002803444
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28