Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay

FDA device recall Z-0110-2016 · posted 2015-10-07 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Status

Terminated

Product code

CDP

Quantity affected

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

Date initiated

2015-08-31

Date posted

2015-10-07

Date terminated

2016-05-16

Location

Brea, CA

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