FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
- Recall number
- Z-0110-2016
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
- Status
- Terminated
- Initiated
- 2015-08-31
- Posted
- 2015-10-07
- Terminated
- 2016-05-16
- Reason
- Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
- Root cause
- Under Investigation by firm
- Action
- Beckman Coulter sent an " Urgent Medical Device Recall" letter dated August 31, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that some Access Free T3 reagent packs (p/n A13422) of lot 431433 were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at http://ww.beckmancoulter.com; call (800) 854-3633 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter representative.
- Quantity
- 16,648 units total (1874 units in US)
- Distribution
- Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
- Lot, serial or model codes
- Lot: 431433
- 510(k) numbers
- ["K960913"]
- PMA numbers
- not on file
- Product code
- CDP
- 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