Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14558 |
| Brand Name: | Panbio Dengue IgM Capture ELISA |
| Model: | E-DEN01M/ E-DEN01M05 |
| Affected: | 12306, 12358 and 13007 |
| 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: | Inverness Medical Innovations Australia Pty Ltd t/a Alere |
| Issue: | Manufacturer's QA program has determined that a reassignment of a customer aceptance range is required for three lots of product. Manufacturer received 5 complaints of invalid test runs due to results falling outside the cut-off value customer accetpance range leading to an invalid test. Analysis has indicated that the invalid test runs are due to the customer acceptance range being inappropriately assigned for these batches. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/4/2013 |
