Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14800 |
| Brand Name: | Bio-Rad- IH-1000 Analyser |
| Model: | Model: 001000 |
| Affected: | All software versions |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Laboratories Inc |
| Issue: | Under specific conditions inconsistent grading between the results in the well/card and the results returned by the IH-1000 may be observed. this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. A result is returned as negative while the reaction is positive, DP, or requires a human interpretation and, 2. This negative result is consistent with the global interpretation of the test and, 3. The system is configured without the second reading function activated for all tests results. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/6/2013 |
