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Recall Observatory FDA recall evidence

Device product

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Z-1388-2018

February 07, 2018

Class II

Product summary

Firm
Life Technologies Corporation
Event
Event 79603
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1388-2018

Official wording

Reason: 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)

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)