| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00289-1 |
| Product Name/Description |
epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnostic medical device (IVD).
Catalogue Number: CT-1004-00-00
Lot Numbers: 07-12289-00 & 07-01263-00
ARTG Number: 198588 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that the referenced lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of Glucose test sensor. Specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 – 30 % has been observed in sample with glucose levels greater than 22 mmol/L. All glucose measurements between the low end of the reportable range and 22 mmol/L are accurately reported, as are all other assay results in the affected cards. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is instructing end users to discontinue the use of, and to destroy, any remaining affected units. Unaffected kits will be provided to customers by Alere to replace the recalled units. |
| Contact Information |
07 3363 7711 - Alere Technical Support |