| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00225-1 |
| Product Name/Description |
iQ200 Series Urine Microscopy Analysers
Part Numbers: 700-3345, 700-3375, 700-3325, 700-3347
Model Numbers: 700-3345-iQ200 Select, 700-3375-IQ Elite, 700-3325-iQ200 Sprint, 700-3347-iQ Select
Manufactured between Jul 2000 to Jan 2017
ARTG Number: 177999 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting “per low-power field (/LPF)” or “per microliter (/µl). This may occur during initial method validation or if settings are altered after the initial validation. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Beckman Coulter is advising they will contact users to schedule a site visit to verify the reporting units of measurement for casts for their laboratory within 90 days of this recall initiation. |
| Contact Information |
1800 060 881 - Customer Support Centre |