Z-2621-2010

Access Immunoassay Systems CORTISOL, Part Number: 33600

Name: Z-2621-2010 Access Immunoassay Systems CORTISOL, Part Number: 33600
Creator: Beckman Coulter Inc.
Published: 2010-02-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-17 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems CORTISOL, Part Number: 33600 on 2010-02-17. The reason FDA records is "The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2621-2010
Status: Terminated
Initiated: 2010-02-17
Posted: 2010-09-29
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems CORTISOL, Part Number: 33600
Product code: CGR Radioimmunoassay, Cortisol
Reason for recall: The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I
FDA root cause: Other
Action: Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed : (1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828; (3) Outside of the United States and Canada, contact your local Beckman Coulter Representative. If consignees need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.
Quantity in commerce: 7282 units
Distribution: United States & Canada
Product codes and lots: Lot Number: 913550

Product code CGR

K954733Class IIAccess Cortisol Assay (Modification)Bio-Rad Laboratories, Inc. / cleared 1995-12-05

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)