Z-1685-2011

Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use

Name: Z-1685-2011 Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use
Creator: Beckman Coulter Inc.
Published: 2010-04-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-04-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use on 2010-04-22. The reason FDA records is "Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1685-2011
Status: Terminated
Initiated: 2010-04-22
Posted: 2011-03-17
Terminated: 2012-05-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.
Product code: CGF Radioimmunoassay, Estrone
Reason for recall: Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. Lots 992637, 100115A, 100205A, 100205RA, and 100226A have now expired and should not be in active use any more.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions: *For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications. *For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the light of additional applicable tests, patient's clinical status and clinical history of patient. Beckman Coulter has finalized the process of re-adjusting Estrone calibrators' values assignment to the new internal reference calibrator starting with lot 100403A. If consignees need products for additional tests they were told to follow replacement instructions below: *In the United States, please contact Customer Service at 1-800-526-3821 *Outside the United States, contact your local Beckman Coulter Representative. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They were to also complete and return the enclosed response form within 10 days so the firm can be assured that consignees received the notification. Consignees were instructed to forward any other questions regarding the notification to the DSL Technical Support Center at 1-800-231-7970 in the United States, or contact their local Beckman Coulter Representative.
Quantity in commerce: 917 units
Distribution: Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.
Product codes and lots: Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA

Product code CGF

K935013Class IDsl Estrone (Dsl 8700)Diagnostic Systems Laboratories, Inc. / cleared 1994-06-16

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)