Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-0613-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.

Product Classification:

Class II

Date Initiated: July 27, 2011

Date Posted: January 2, 2013

Recall Number: Z-0613-2013

Event ID: 61212

Reason for Recall:

A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.

Status: Terminated

Product Quantity: 6,634 units total (2,742 units in US)

Code Information:

019818, 021654, 024072

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.

Voluntary or Mandated:

Voluntary: Firm initiated