Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13243 |
| Brand Name: | Abbott ARCHITECT Toxoplasma reagent |
| Model: | 6C19-25 |
| Affected: | 15070L100 and 15070L101 |
| 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: | ARCHITECT Toxo IgG reagents lots are showing reduced specificity which may cause a shift to higher IU/ml values leading to increased grayzone and/or reactive results. The assay sensitivty is not impacted and current data indicates that no other lots are affected. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/8/2012 |
