Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25363 |
| Brand Name: | ARCHITECT CRP Vario and Alinity c CRP Vario Reagent Kits |
| Model: | |
| Affected: | Multiple Lots |
| 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 Australasia Pty Ltd (NZ) |
| Issue: | Internal studies were carried out by the manufacturer of the ARCHITECT CRP Vario and Alinity c CRP Vario reagents, to verify the sample stability claims in the current Instructions for Use. The manufacturer has confirmed that the EDTA specimen collection tube type (Dipotassium and Tripotassium) did not meet the sample storage stability claim listed in the package insert and is no longer appropriate for use. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/11/2019 |
