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.
This recall has been terminated (originally issued December 22, 2012).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 27, 2011
- Posted
- December 22, 2012
- Terminated
- December 26, 2012
- Recall Number
- Z-0613-2013
- Quantity
- 6,634 units total (2,742 units in US)
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
019818, 021654, 024072
Root Cause
Nonconforming Material/Component
Action Taken
A recall communication was initiated on July 27, 2011 with Beckman forwarding a Product Corrective Action (PCA) letter with attached PCA response form to all their customers who purchased the Access Immunoassay Systems Total T4 Calibrators. The letter provides the customers with an explanation of the problems identified and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers can call for product replacement in the US, by contacting Client Services at (800) 526-3821, option 1. Customers in Canada can contact Customer service at (800) 463-7828. Customers with questions regarding this notice can contact Customer Support Center at http:www.beckmancoulter.com or call (800) 854-3633 in the US and Canada.