Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Cr
FDA device recall Z-0650-2014 · posted 2014-01-09 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
- Action taken
- 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
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- est. 200,000
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-10-10
- Date posted
- 2014-01-09
- Date terminated
- 2014-03-24
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS (K070068) | Nova Biomedical Corp. | 2007-05-07 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K063821) | Nova Biomedical Corp. | 2007-01-24 |
| NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS (K060345) | Nova Biomedical Corp. | 2006-04-28 |