FDAClass IIApril 25, 2018

Human Fetal Hemoglobin recall

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Why was Human Fetal Hemoglobin 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)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Recalling firm
Life Technologies Corporation
Distribution
MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls