Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200

FDA device recall Z-1313-06 · posted 2006-08-01 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.

Action taken

A Product Corrective Action letter was sent via US mail the week of April 10, 2006 to all Access CEA customers informing them that the Access CEA Assay could generate decreased values with certain frozen patient specimens. Although they have found it at a low occurrence, it is recommended that specimens should not be frozen prior to analysis until further notice. The letter informs customers that Beckman Coulter has verified sample stability through at least 14 days when properly stored at 2-8 degrees Celsius and shipping stability for 4 days at 2-8 degrees Celsius using cool packs. Firm also advises customers to contact customer technical support or local Beckman Coulter Representative if laboratory is unable to avoid freezing specimens and to review results from frozen CEA samples to ensure that the match the total clinical presentation per the customer''s established laboratory procedure. The letter requests that the notification remain part of the laboratory Quality System documentation and that the response form be returned to the firm within 10 days.

Root cause

Other

Status

Terminated

Product code

DHX

Quantity affected

775

Distribution

Nationwide and Canada

Date initiated

2006-04-12

Date posted

2006-08-01

Date terminated

2012-04-03

Location

Brea, CA

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