Z-1426-2020 Class II Terminated
FDA device recall Z-1426-2020 was initiated by Beckman Coulter Inc on August 15, 2019 and is designated Class II. Reason for recall: It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to… The recall status is terminated (terminated February 28, 2024). Affected quantity: 25,383 Reagents.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- August 15, 2019
- Termination Date
- February 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,383 Reagents
Product Description
Reason for Recall
Distribution Pattern
Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas,Utah,Virginia,Washington,West Virginia, Wisconsin,Wyoming Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Curacao, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Guyana, Hong Kong, India, Ireland, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Netherlands, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam