Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14449 |
| Brand Name: | Epoc BGEM Test Cart |
| Model: | Catalogue No.: CT-1004-00-00 |
| Affected: | Lot: 07-12289-00, 07-12363-00 |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd - Rapid Diagnostics Divison Ground Floor, Bldg. D 4 Pacific Rise Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 466 951 |
| Manufacturer: | Epocal Inc |
| Issue: | Affected 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. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/4/2013 |
