Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1303-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Product Classification:

Class II

Date Initiated: February 8, 2024

Date Posted: March 27, 2024

Recall Number: Z-1303-2024

Event ID: 94012

Reason for Recall:

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

Status: Ongoing

Product Quantity: 64,009 kits

Code Information:

Lot numbers: 338555, exp. 31 JUL 2024; 338556, exp. 31 AUG 2024; 338734, exp. 30 SEP 2024; and 338958, exp. 31 OCT 2024; UDI-DI 15099590225742.

Distribution Pattern:

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Bangladesh, Bolivia, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Egypt, El Salvador, Georgia, Greece, Hong Kong, India, Kazakhstan, Mexico, Namibia, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Taiwan, Thailand, Turkey, U.A.E, Vietnam, and Zimbabwe.

Voluntary or Mandated:

Voluntary: Firm initiated