FDA-Device2018-04-18Class II
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
Beckman Coulter Inc.
Hazard
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.
Sold states
United States: nationwide, including Puerto Rico; and Foreign: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Bermuda, Bolivia, Brazil, Brunei Darussalam, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mexico, Moldova, Republic Of, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, United Kingdom, United States, Uruguay, Venezuela, Vietnam
Affected count
4350 total units (1713 in U.S.)
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2018Don't want to check this manually?
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