FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-2184-2011
- Recalling firm
- Beckman Coulter 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.
- Status
- Terminated
- Initiated
- 2011-03-30
- Posted
- 2011-05-11
- Terminated
- 2011-12-02
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830
- 510(k) numbers
- ["K951707"]
- PMA numbers
- not on file
- Product code
- CFL
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28