Device Recall IGFBP3 ELISA Reagent Kit 의 리콜

Recall

58583

Class 2

Z-2184-2011

2011-03-30

2011-05-11

Terminated

United States

2011-12-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99627

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).

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.