Nova StatStrip/StatSensor Hospital Blood Glucose Meter recallZ-0650-2014 · Nova Biomedical Corporation · initiated Oct 10, 2013
Class II Terminated All recalls posted in January 2014
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 Nova Biomedical Corporation 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
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
FDA root cause category: Component design/selection
What the company is doing
On November 18, 2013, an URGENT Field Correction Letter was sent to all StatStrip Glucose Hospital meter, StatStrip Lactate Hospital Meter and StatSensor Creatinine Hospital Meter customers via email to the Point of Care Coordinator to alert users that lithium batteries that are utilized beyond their intended useful life may swell and/or crack posing a potential safety hazard. In some cases, the swelling may potentially cause the battery door on the meter to dislodge and render the meter inoperable.
Recall details
- Recall number
- Z-0650-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 10, 2013
- Posted by the FDA
- Jan 9, 2014
- Recalling firm
- Nova Biomedical Corporation
- Quantity
- est. 200,000
- Product code
- CGA
- FDA submissions
- K060345, K063821, K070068
- Distribution
- Nationwide Distribution.
Product description
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Code information (models, lots, serial numbers)
All serial numbers
Other devices under the same FDA submission
3 devices cleared under K060345, K063821, K070068 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STATSENSOR 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE5 reports
- StatSensor 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE3 reports
- StatSensor 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE2 reports
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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