| 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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 060 881 - Customer Support Centre |