Z-2047-2011

Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent...

Name: Z-2047-2011 Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent...
Creator: Beckman Coulter Inc.
Published: 2009-08-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-08-03 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the... on 2009-08-03. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned...". 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-2047-2011
Status: Terminated
Initiated: 2009-08-03
Posted: 2011-04-20
Terminated: 2012-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Active Prolactin ELISA, 96 Wells, DSL-10-4500 The DSL-10-4500 Active Prolactin Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of prolactin in human serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
Product code: CFT Radioimmunoassay, Prolactin (Lactogen)
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the Active Prolactin ElLISA kit, lot number 890291 over estimates the expected dose values for patient serum samples due to a shift in the assigned calibrator values. Beckman Coulter recommends that patient results generated with the affected lot be evaluated in the context of other diagnostic tests and the clinical presentatio
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" Letter dated August 03, 2009 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: Action/Resolution: Discontinue use and discard remaining product with lot number 890291 of Active Prolactin reagents. Contact Beckman Coulter at 1-800-231-7970 for replacement product. Newer lots (lot number 991210 or higher) of the product have been realibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, they were told to contact Technical support at the phone number listed below. Consignees were asked to share this information with their laboratory staff and retain this letter for their Quality System documentation and asked to complete and return the enclosed response form within 10 days via fax to: 786-639-4000 so that Beckman can be assured that they received the notification. If you have any other questions regarding this notification, please contact DSL Technical Support Center at 1-800-231-7970 in the United States and Canada , or contact their local Beckman Coulter Representative.
Quantity in commerce: 30 Kits
Distribution: Nationwide distribution: USA including states of: FL, GA and NC.
Product codes and lots: Lot Number: 890291

Product code CFT

K960561Class IDsl Active Prolactin Elisa Model 10-4500Diagnostic Systems Laboratories, Inc. / cleared 1996-04-26

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)