Recalls / —

—#46516

Product

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

FDA product code

DHX — System, Test, Carcinoembryonic Antigen

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K981985

Affected lot / code info

All codes

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2006-04-12

Posted by FDA

2006-08-01

Terminated

2012-04-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #46516. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.