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

iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100.
Recall Number Z-1366-2018

REASON
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea CA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4350 total units (1713 in U.S.)

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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