Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18899 |
| Brand Name: | Iris iChem Velocity Automated Urine Chemistry System |
| Model: | 800-3042, 800-3043, 800-3044, 800-3075, 800-3076, 800-3564, 800-7100, 800-7101, 800-7102, 800-7103, 800-7106, 800-7157, 800-7162, 800-7163, 800-7166 |
| Affected: | Manufactured between Apr-2011 and Jun-2015 |
| 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: | IRIS has confirmed the iChem Velocity Automated Urine Chemistry Systems do not maintain the on-board strip stability claim of 10 days at 18-28 degrees C at 20-80% relative humidity as stated in the product labeling. The on-board strip stability is affected by temperature and humidity in the laboratory. If a laboratory operates outside of the defined parameters , test results may be affected as indicated below: * False low or false negative results: Ketone, Blood * False high or false positive results: Bilirubin, Urobilinogen, Glucose, Nitrite * False high results: Leukocytes Ascorbic Acid, Protein and pH are not affected. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/7/2015 |
