| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01322-1 |
| Product Name/Description |
Nova StatStrip and StatSensor Blood Monitoring Systems. An in vitro diagnostic medical device (IVD)
(Point of Care System)
ARTG Number: 197482
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
This recall action is to alert users that Lithium batteries utilized beyond their intended useful life may swell and/or crack the external case posing a potential safety hazard. In some cases, the swelling may cause the battery door on the meter to incorrectly seat rendering the meter inoperable. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AMSL is advising users that all batteries without an expiration date label will be replaced. AMSL recommends a battery inspection program is implemented to identify and remove batteries from point of use that do not have expiration dates on the battery label. |
| Contact Information |
02 9882 3666 - AMSL Point of Care |