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Beckman Coulter Inc. recalls Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended t
Recalled January 2, 2013 · FDA recall Z-0613-2013 · Beckman Coulter
Hazard
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. · FDA Class II
Units
6,634 units total (2,742 units in US)
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →