Z-2184-2011

IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432...

Name: Z-2184-2011 IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432...
Creator: Beckman Coulter Inc.
Published: 2011-03-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-03-30 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro... on 2011-03-30. The reason FDA records is "The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU)". 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-2184-2011
Status: Terminated
Initiated: 2011-03-30
Posted: 2011-05-11
Terminated: 2011-12-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830 This assay is intended for in vitro diagnostic use.
Product code: CFL Radioimmunoassay, Human Growth Hormone
Reason for recall: The recall was was initiated because patient results with the IGFBP-3 ELISA kit may be elevated by 70% compared to stated expected ranges in the Instructions for Use (IFU).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter sent a Product Corrective Action (PCA) letter with attached customer response form on March 30, 2011 to all customers who have the affected product, IGFBP- 3 Enzyme-Linked immunosorbent Assay ( ELISA) kit .This kit provides materials for the quantitative measurement of IGFBP-3 in serum. The letter informed the customers of the reason for recall, the products affected and actions to be taken. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they were asked to provide a copy of the letter to them. Beckman further asked consignees to complete and return the enclosed Response Form within 10 days so they are assured consignees have received this important communication. Questions were directed to the Beckman Coulter Customer Support Center. - Website: http://www.beckmancoulter.com/customersupport/support - Phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada contact local Beckman Coulter representative.
Quantity in commerce: 1,212 units
Distribution: Worldwide -- USA, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Italy, Korea, Republic of, Lebanon, Luxembourg, Morocco, Netherlands, New Zealand, Puerto Rico, Syrian Arab Republic, Taiwan, Thailand, Turkey & United Kingdom
Product codes and lots: Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830

Product code CFL

K951707Class IDsl Active Ifgbp-3 ElisaDiagnostic Systems Laboratories, Inc. / cleared 1995-05-10

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)