18
Apr
2018

iQ200 Series Urine Microscopy Analyzer ; Cl II

0

Company:Beckman Coulter Inc.
Date of Enforcement Report 4/18/2018
Class lI:

PRODUCT

BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer
Recall Number Z-1362-2018

REASON
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. This may occur during initial method validation or if settings are altered after the initial validation.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea CA on 3/2/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5247 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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