Recall Z-0650-2014 ยท CGA Glucose Oxidase, Glucose
Nova Biomedical Corporation
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.
| Date | Jan 9, 2014 (initiated Oct 10, 2013) |
| Status | Terminated |
| Reason | Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage |
| 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 | est. 200,000 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS Nova Biomedical Corp., Apr 28, 2006 |
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp., Jan 24, 2007 |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS Nova Biomedical Corp., May 7, 2007 |