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Z-1388-2018 Class II Terminated

Recalled by Life Technologies Corporation — Frederick, MD

Recall Details

Product Type
Devices
Report Date
April 25, 2018
Initiation Date
February 7, 2018
Termination Date
May 8, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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 Pattern

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

Code Information

Model # MHFH01 UDI (01)10190302005579(17)180430 (10)1626670D(240)MHFH01 Lot# 1626670D Model # MHFH01 UDI (01)10190302005579(17)190830 (10)1873068B(240)MHFH01 Lot# 1873068B Model # MHFH01 UDI (01)10190302005579(17)191030 (10)1915224B(240)MHFH01 Lot# 1915224B

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