Device product
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.
Z-0650-2014
Product summary
- Event
- Event 66398
- Status
- Terminated
- Classification
- Class II
- Quantity
- est. 200,000
- Official record key
device-enforcement:Z-0650-2014
Official wording
Reason: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Code information: All serial numbers
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage