Z-1366-2018 Class II Terminated
FDA device recall Z-1366-2018 was initiated by Beckman Coulter Inc. on November 10, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 21, 2022). Affected quantity: 4350 total units (1713 in U.S.).
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- November 10, 2017
- Termination Date
- December 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4350 total units (1713 in U.S.)
Product Description
Reason for Recall
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