PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 15, 2014 Initiated: October 10, 2013 #Z-0650-2014

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.

Reason for Recall

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

Details

Units Affected
est. 200,000
Distribution
Nationwide Distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Nova Biomedical Corporation. Units affected: est. 200,000.
Why was this product recalled?
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Which agency issued this recall?
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0650-2014.