Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23352 |
| Brand Name: | IH-Com Fullversion |
| Model: | |
| Affected: | |
| Software version: | version 5.1 only |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Laboratories Inc |
| Issue: | The manufacturer has identified a software anomaly in IH-Com version 5.1. This anomaly only affects the QC module for ABO forward grouping of IH-Com. The software allows the release of a QC result ("QC accepted") which is discrepant with the claimed result in the conditions described below: 1. Process ABO forward grouping tests with QC samples. 2. The QC result is not as expected due to a potential failure of instrument or reagents. 3. Obtain a discrepant result with the claimed result. 4. IH-Com displays a "QC passed" while it should be displayed as "QC failed". |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/7/2018 |
