FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
- Recall number
- Z-1000-2011
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Abbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
- 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, 1,000,000 strips per lot
- Distribution
- Products were released for distribution in US and Puerto Rico.
- Lot, serial or model codes
- Lot codes: 45358, 45369, 45377, 45379, 45466, 45504, 45511, 45608, 45613, 45641, 45642, 45644, 45672, 45674, 45675, 45676, 45677, 45721, 45734, 45736, 45739, 45742, 45743, 45789, 45790, 45800, 45801, 45840, 45841, 45849, 45850, 46008, 46009, 46061, 46067, 46069, 46072, 46103, 46105, 46148, 46201, 46202, 46214, 46215, 46232, 46313, 46332, 46336, 46338, 46341, 46368.
- 510(k) numbers
- ["K083223"]
- 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