Beckman Coulter ACCESS Immunoassay Systems recall
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of…
Why was Beckman Coulter ACCESS Immunoassay Systems recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 33830; all lots.
- Product
- Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 238,862
- 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.
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)