FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue Blood Glucose Test Strips;
- Recall number
- Z-0999-2011
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue 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, 1,000,000 strips per lot.
- Distribution
- Products were released for distribution in US and Puerto Rico.
- Lot, serial or model codes
- Lot codes: 45001A330, 45001A467, 45001A481, 45001A482, 45001A483, 45001A487, 45001A488, 45001A496, 45001A497, 45001A499, 45001A500, 45001A503, 45001A505, 45001A506, 45001A510, 45001A511, 45001A513, 45001A519, 45001A520, 45001A521, 45001A530, 45001A532, 45001A534, 45001A536, 45001A537, 45001A545, 45001A556, 45001A565, 45001A566, 45001A568, 45001A573, 45001A577, 45001A584, 45001A594, 45001A595, 45001A597, 45001A605, 45001A607, 45001A608, 45001A609, 45001A613, 45001A614, 45001A626, 45001A634, 45001A637, 45001A641, 45001A644, 45001A645, 45001A656, 45001A660, 45001A664, 45001A669, 45001A670, 45001A671, 45001A677, 45001A678, 45001A682, 45001A685, 45001A694, 45001A700, 45001A705, 45001A706, 45001A707, 45001A709, 45001A712, 45001A730, 45001A732, 45001A739, 45001A742, 45001A744, 45001A751, 45001A753, 45001A757, 45001A762, 45001A777, 45001A778, 45001A786, 45001A788, 45001A790, 45001A798, 45001A806, 45001A814, 45001A815, 45001A816, 45001A820, 45001A840, 45001A842, 45001A847, 45001A852, 45001A856, 45001A860, 45001A861, 45001A872, 45001A876, 45001A882, 45001A910, 45001A912, 45001A914, 45001A918, 45001A920, 45001A921, 45001A940, 45001A947, 45001A948, 45001A949, 45001A971, 45001A976, 45001A979, 45001A982, 45001A983, 45001C008, 45001C011, 45001C012 45384, 45388, 45396, 45407, 45418, 45455, 45456, 45463, 45464, 45512, 45514, 45516, 45521, 45611, 45612, 45614, 45619, 45627, 45632, 45639, 45645, 45646, 45653, 45670, 45679, 45680, 45682, 45707, 45708, 45724, 45729, 45731, 45732, 45733, 45735, 45737, 45738, 45755, 45777, 45782, 45783, 45784 Precision Xtra Blood Glucose & Ketone Monitoring System: 01P107D, 01P128D, 01P139D, 02P140D, 01P153D, 02P201D, 02P223D, 02P229D, 03P107D, 03P155D, 03P158D, 03P194D, 03P209D, 03P222D, 03P223D, 03P242D, 04P154D, 04P194D, 04P201D, 04P315D, 05P106D, 05P107D, 05P127D, 05P130D, 05P138D, 05P139D, 05P140D, 05P152D, 05P201D, 06P180D, 06P322D, 07P141D, 08P106D, 08P138D, 08P279D, 09P106D, 09P140D; Precision G3b Smartblue Blood Glucose Test Strips: 45001A710.
- 510(k) numbers
- ["K051213"]
- 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