Z-2081-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- April 3, 2017
- Termination Date
- May 31, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128,718 units total (47,858 units in US)
Product Description
Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Reason for Recall
Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.
Distribution Pattern
Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.
Code Information
all lots