Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay f

FDA device recall Z-2108-2016 · posted 2016-06-30 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Demonstrate an upward shift in patient results.

Action taken

Beckman Coulter sent an " Urgent Medical Device Recall" letter dated June 8, 2016, to all affected customers. Beckman Coulter has determined through customer feedback and internal testing that the Access Free T3 Reagent lots listed above demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots. The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center at http:www.beckmancoulter.com, call (800) 854-3633 in US and Canada. Customers outside US and Canada, are instructed to contact local Beckman Coulter representative.

Root cause

Device Design

Status

Terminated

Product code

CDP

Quantity affected

205,744 kits total (13,358 kits in US)

Distribution

Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Can

Date initiated

2016-06-08

Date posted

2016-06-30

Date terminated

2017-04-18

Location

Brea, CA