—#99627

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.

FDA product code: CFL — Radioimmunoassay, Human Growth Hormone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K951707
Affected lot / code info: Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2011-03-30
Posted by FDA: 2011-05-11
Terminated: 2011-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.