Device Recall ARCHITECT Ferritin Reagent 의 리콜

Recall

35612

Class 3

Z-1204-06

2006-06-06

2006-07-04

Terminated

United States

2008-01-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46468

Some architect ferritin reagent lots may not be meeting the accuracy by correlation to axsym claims as they are listed in the package insert (slope of 1.0 +/- 0.2).

Abbott international affiliates were e-mailed copies of the recall letter on 6/6/06 for translation where needed and dissemination to their accounts receiving the affected product. The end users were advised that a shift in patient and/or control results occurs when changing to reagent and calibrator lots manufactured using the new internal reference standard, and that the accuracy by correlation between Architect and AxSYM Ferritin reagent lots does not match those stated in the package insert. The accounts advised to set new targets for their controls or use the enclosed targets in Attachment A when they change to the assay materials manufactured using the new internal reference standards. The accounts were requested to keep a copy of the letter on file until the revised package insert is received.