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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