Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-2108-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Product Classification:

Class II

Date Initiated: June 8, 2016

Date Posted: July 6, 2016

Recall Number: Z-2108-2016

Event ID: 74393

Reason for Recall:

Demonstrate an upward shift in patient results.

Status: Terminated

Product Quantity: 205,744 kits total (13,358 kits in US)

Code Information:

524087 526807 528874 529913 530102 531647 532473 534080 534081 534336 535481 570090 570116 570222 570236 570239 570245 570246 622173 622174 671016 671025 671033

Distribution Pattern:

Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe

Voluntary or Mandated:

Voluntary: Firm initiated