FDA recall Z-1388-2018

Product

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Reason for recall

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)

Distribution

MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA

Key facts

Status

Terminated

Initiation date

2018-02-07

Report date

2018-04-25

Termination date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Frederick, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2018