Recall Z-2607-2010 ยท CFL Radioimmunoassay, Human Growth Hormone
Beckman Coulter Inc.
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.
| Date | Sep 28, 2010 (initiated Aug 9, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF |
| Root cause | Pending |
| Action | The recall communication was initiated with a Product Corrective Action (PCA) letter that was sent on August 09, 2010 to all customers who received the IGFBP-3 IRMA kits, lot numbers referenced. The letter will provide the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: (1) Discontinue using all lots identified above and discard in accordance with local regulations. (2) To continue testing for IGFBP-3 levels, find an alternate method. (3) Immediately notify all parties of interest (e.g., laboratory staff, clinicians) of the pos |
| Quantity | 63 |
| Distribution | Nationwide in US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) Diagnostic Systems Laboratories, Inc., Feb 22, 1995 |