Z-0650-2014Class II

Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova...

Name: Z-0650-2014 Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova...
Creator: Nova Biomedical Corporation
Published: 2013-10-10
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2013-10-10 / Terminated / root cause: design

FDA source

Nova Biomedical Corporation began a recall of Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable... on 2013-10-10. FDA classified it as Class II and gives the reason as "Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0650-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2014-01-09
Terminated: 2014-03-24
Recalling firm: Nova Biomedical Corporation
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.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: est. 200,000
Distribution: Nationwide Distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0650-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0650-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

Product code CGA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)