Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Rea

FDA device recall Z-1318-2010 · posted 2010-04-12 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with UniCel Dxl systems have been demonstrated to have a positive bias compared to values obtained with Access or Access 2 systems.

Action taken

An "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated February 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers are recommended to immediately discontinue using AccuTnI Reagents and Calibrators on the UniCel DxI system until further notice. If this is not possible, the customers are directed to notify their stakeholders of the bias until further notice. The customers should complete, fax (786-639-4000) or mail the enclosed RESPONSE FORM. If consignees need assistance or have any questions regarding the notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.

Root cause

Other

Status

Terminated

Product code

MMI

Quantity affected

196,071 kits

Distribution

Worldwide distribution: USA and Canada

Date initiated

2010-02-06

Date posted

2010-04-12

Date terminated

2012-05-09

Location

Brea, CA

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