Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15374 |
| Brand Name: | Trinity Biotech Captia Cytomegalovirus (CMV) IgG |
| Model: | Product Code: 2325200 |
| Affected: | Lot Number: 557 |
| Software version: | |
| Recalling Organisation: | Banksia Scientific Pty Ltd (NZ) 12 Brigade Street Airport Oaks Auckland |
| Contact Information: | 09 921 2626 |
| Manufacturer: | Trinity Biotech |
| Issue: | Upon review of the QA release testing, the range that was calculated at the time of kit release was calculated per standard operating procedures and supports the Positive Control range that was assigned upon release of 2.2-4.1. However, upon investigation of history (as a Positive Control in several kit lots) and additional testing it has been re-evaluated and determined that this range requires an adjustment to 2.2-4.6. If you have used this kit lot to test and report patient results, and the Positive Control was within the assigned range (2.2-4.1), then the reported patient results were valid. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/9/2013 |
