Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20427 |
| Brand Name: | Alere INRatio PT/INR Monitor System |
| Model: | HS0100267 HS0200431 HS0200433 HS200433SJM HS200433SJMK HS0100071 HS0100139 HS99007G1 and HS99008G1 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd - Rapid Diagnostics Divison Ground Floor, Bldg. D 4 Pacific Rise Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 466 951 |
| Manufacturer: | Alere Medical Co Ltd |
| Issue: | Measures taken by Alere to address the potential for the device to provide an incorrect INR result, including software improvements and changes to the Instructions for Use, have not adequately mitigated previously identified risks. This device is now being withdrawn from the market. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/7/2016 |
