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.
FDA Recall Z-0650-2014 · Posted 2014-01-09
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Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCGA
Date Initiated2013-10-10
Date Terminated2014-03-24
Product Quantityest. 200,000
Reason for Recall
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp. · 2007-05-07K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corp. · 2007-01-24K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSNova Biomedical Corp. · 2006-04-28
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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