Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15590 |
| Brand Name: | Microgenics CEDIA Tobramycin II Assay |
| Model: | Catalogue Number: A96842 |
| Affected: | Lot: 60169764 |
| Software version: | |
| Recalling Organisation: | Beckman Coulter NZ Ltd Suite 2, Level 4 30 St Benedicts Street Newton AUCKLAND |
| Contact Information: | 0800 446 109 |
| Manufacturer: | Microgenics Corporation |
| Issue: | In-house testing of the CEDIA® Tobramycin II Assay (LN: 60169764) shows that the reconstituted reagents do not maintain 30 days reconstituted stability. The instability of the reconstituted reagents may cause higher recovery of samples. Hence, lot number 60169764 reagents must be used within 14 days after reconstitution. Reconstituted reagents beyond the 14 days should be discontinued and discarded. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/10/2013 |
