Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23406 |
| Brand Name: | ARCHITECT EBV VCA IgM reagent |
| Model: | |
| Affected: | lots 85278LI00 and 85279LI00 |
| Software version: | |
| Recalling Organisation: | Abbott Australasia Pty Ltd (NZ) Abbott Laboratories NZ 4 Pacific Rise, Mt Wellington Auckland 1060 |
| Contact Information: | 61 2 93849717 |
| Manufacturer: | Abbott Diagnostics |
| Issue: | The manufacturer has identified the two ARCHITECT EBV VCA IgM Reagent lots listed above may show reduced RLU (Relative Light Units) signal when used in combination with certain lots of ARCHITECT EBV VCA IgM Calibrator (LN 3P66-01). This reduced RLU signal may cause up to a 20% decrease in cutoff RLU values in assay calibration resulting in: Upward shift in Quality Control S/CO values False grayzone patient results in the range of 0.50-0.60 S/CO False reactive patient results in the range 1.00-1.20 S/CO |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/7/2018 |
