GHQClass II

Stain, Fetal Hemoglobin

Hematology · 21 CFR 864.7455

MDR events1All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances2All time

Recent MDR events

1 adverse event reports on file

*Dec 10, 2002
Malfunction*MW4003423

Event type breakdown

Malfunction1

Most-reported manufacturers

Recalls

1 recall events for this product code

Life Technologies Corporation
TerminatedUnknown
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
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)
Z-1388-2018 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

2 clearances for this product code