FDA-Device2014-01-15Class II

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.

Nova Biomedical Corporation
Hazard

Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage

Sold states
Nationwide Distribution.
Affected count
est. 200,000
Manufactured in
200 Prospect St, Waltham, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2014

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