Z-1313-06

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

Name: Z-1313-06 Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Creator: Beckman Coulter Inc
Published: 2006-04-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-04-12 / Terminated

FDA source

Beckman Coulter Inc began a recall of Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200 on 2006-04-12. The reason FDA records is "Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1313-06
Status: Terminated
Initiated: 2006-04-12
Posted: 2006-08-01
Terminated: 2012-04-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Product code: DHX System, Test, Carcinoembryonic Antigen
Reason for recall: Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.
FDA root cause: Other
Action: 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.
Quantity in commerce: 775
Distribution: Nationwide and Canada
Product codes and lots: All codes

Product code DHX

K981985Class IIAccess Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209Beckman Coulter, Inc. / cleared 1998-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)