Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20033 |
| Brand Name: | IRISpec CA/CB/CC and IRISpec CA/CB |
| Model: | 800-7211, 800-7702 and 800-0074 |
| Affected: | Lot Numbers: 336-15, 343-15, 004-16, 006-16, 019-16, 021-16, 313-15, 336-15, 004-16, 309-15 |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Iris International |
| Issue: | There is an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the IRISpec CA bilirubin control material. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/4/2016 |
