Z-2081-2017 Class II Terminated
FDA device recall Z-2081-2017 was initiated by Beckman Coulter Inc. on April 3, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 31, 2018). Affected quantity: 128,718 units total (47,858 units in US).
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
Reason for Recall
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.