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Recall Observatory FDA recall evidence

Device product

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

Z-1366-2018

November 10, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 79368
Status
Terminated
Classification
Class II
Quantity
4350 total units (1713 in U.S.)
Official record key
device-enforcement:Z-1366-2018

Official wording

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.

Code information: All iQ200 Series in the field with barcode reader model NFT-2100

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.