Medical device recalls Moderate risk

Life Technologies Corporation recalls Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Recall date
February 7, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1388-2018
FDA classification
Class II
Brand / firm
Life Technologies Corporation
Sold / distributed
MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA

Why it was recalled

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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

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