Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26840 |
| Brand Name: | ARCHITECT EBV VCA IgM Calibrator |
| Model: | |
| Affected: | Lot number - 08159BE00 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics Division Ground Floor, Building D 4 Pacific Rise Mt Wellington AUCKLAND 1640 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott GmbH & Co. KG |
| Issue: | The manufacturer has identified the ARCHITECT EBV VCA IgM Calibrator lot 08159BE00 may show reduced RLU (Relative Light Units) signal. This reduced RLU signal may cause a decrease in cutoff RLU values in assay calibration resulting in: Upward shift in Quality Control S/CO values Non-reactive to false grayzone patient results in the range of 0.50 - 0.56 S/CO Grayzone to false reactive patient results in the range of 1.00 - 1.13 S/CO |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/11/2020 |
