Retiro De Equipo (Recall) de Device Recall Human Fetal Hemoglobin (HBF1) FITC Conjugate

Recall

79603

Class 2

Z-1388-2018

2018-02-07

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162776

Three lots of human fetal hemoglobin fitc conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.E. false positives).

All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure. The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions.