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.
FDA Recall Z-0110-2016 · Posted 2015-10-07
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeCDP
Date Initiated2015-08-31
Date Terminated2016-05-16
Product Quantity16,648 units total (1874 units in US)
Reason for Recall
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.