Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21964 |
| Brand Name: | Eiken OC-Sensor reagents and controls |
| Model: | |
| Affected: | Changes to the IFU |
| Software version: | |
| Recalling Organisation: | Prohealth Asia Pacific Limited c/-Edge Advisory Level 1 1 Shea Terrace Auckland 0622 |
| Contact Information: | |
| Manufacturer: | Eiken Chemical Co. Ltd. |
| Brand Name: | Eiken iFOBT sample collection tube |
| Model: | |
| Affected: | Changes to the IFU |
| Software version: | |
| Recalling Organisation: | Prohealth Asia Pacific Limited c/-Edge Advisory Level 1 1 Shea Terrace Auckland 0622 |
| Contact Information: | |
| Manufacturer: | Eiken Chemical Co. Ltd. |
| Issue: | The manufacturer has made a change to the product IFU. The product IFU will detail more information on temperature stability and an increased usability.The IFU will extend its range of use from 7 days to 14 days. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/9/2017 |
