Recall Z-2184-2011 ยท CFL Radioimmunoassay, Human Growth Hormone
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.
| Date | May 11, 2011 (initiated Mar 30, 2011) |
| Status | Terminated |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951707 | DSL ACTIVE IFGBP-3 ELISA Diagnostic Systems Laboratories, Inc., May 10, 1995 |