Abbott Diabetes Care, Precision Xtra Blood Glucose Test… recallZ-0999-2011 · Abbott Diabetes Care, Inc. · initiated Dec 22, 2010
Terminated All recalls posted in February 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0999-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 22, 2010
- Posted by the FDA
- Feb 9, 2011
- Recalling firm
- Abbott Diabetes Care, Inc.
- Quantity
- 359 total lots, 1,000,000 strips per lot.
- Product code
- NBW
- FDA submissions
- K051213
- Distribution
- Products were released for distribution in US and Puerto Rico.
Product description
Abbott Diabetes Care, Precision Xtra Blood Glucose Test Strips; Precision Xtra Blood Glucose & Ketone Monitoring System; Precision G3b Smartblue Blood Glucose Test Strips;
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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.
Other devices under the same FDA submission
6 devices cleared under K051213 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Precision Xtra 99694Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose6 reports
- Precision Xtra 99695Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER4 reports
- Precision Xtra 99728Abbott Diabetes Care Inc · SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER3 reports
- Precision Xtra 99877Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose3 reports
- Precision Xtra 80050Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1 report
- Precision Xtra 99838Abbott Diabetes Care Inc · Glucose dehydrogenase, glucose1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 57524).
- Z-0994-2011 · TerminatedAbbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
- Z-0995-2011 · TerminatedAbbott Diabetes Care Optium EZ Blood Glucose Test Strips;
- Z-0996-2011 · TerminatedAbbott Diabetes Care, MediSense Optium Blood Glucose Test Strips; MediSense Optium Blood Glucose Electrodes;
- Z-0997-2011 · TerminatedAbbott Diabetes Care, Optium Blood Glucose Test Strips;
- Z-0998-2011 · TerminatedAbbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;
- Z-1000-2011 · TerminatedAbbott Diabetes Care, ReliOn Ultima Blood Glucose Test ;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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