FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-0613-2013
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-07-27
- Posted
- 2012-12-22
- Terminated
- 2012-12-26
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 6,634 units total (2,742 units in US)
- 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, serial or model codes
- 019818, 021654, 024072
- 510(k) numbers
- ["K023369"]
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28