Z-1905-2021 Class II Terminated
FDA device recall Z-1905-2021 was initiated by Beckman Coulter Inc. on May 7, 2021 and is designated Class II. Reason for recall: SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elev… The recall status is terminated (terminated March 27, 2023). Affected quantity: 13,337 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 30, 2021
- Initiation Date
- May 7, 2021
- Termination Date
- March 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,337 units
Product Description
Reason for Recall
Distribution Pattern
US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates