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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 Beckman Coulter Australia Pty Ltd
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