Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.
- Company
- Beckman Coulter Inc.
- Recall Initiated
- April 30, 2019
- Posted
- June 2, 2020
- Terminated
- December 28, 2021
- Recall Number
- Z-2241-2020
- Quantity
- 150,887
- Firm Location
- Brea, CA
Reason for Recall
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Distribution
US Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusett, 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,South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. US Territories: American Samoa, Guam, and Puerto Rico. OUS Distribution: Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, San Marino, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.
Lot / Code Info
Catalog Number: 387687; all lots.
Root Cause
Other
Action Taken
On 04/30/2019, an Urgent Medical Device Letter was sent via mail to affected consignees. Customers were instructed to access the updated Instructions for Use (IFU) Limitations and Interferences sections for the six affected Access immunoassays on the firm's website. Additionally they ask customers to do the following: 1) Share the information with laboratory staff and retain the notification as part of their laboratory Quality System documentation. If any of the affected product(s) have been forwarded to another laboratory, they are to provide them with a copy of the Urgent Medical Device Recall letter. 2) Respond within 10 days either electronically (if received communication via email) or manually (complete and return an enclosed Response Form). If there are any questions regarding the notice, contact the Customer Support Center: website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact the local firm representative.