Z-1388-2018 Class II Terminated
FDA device recall Z-1388-2018 was initiated by Life Technologies Corporation on February 7, 2018 and is designated Class II. 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.… The recall status is terminated (terminated May 8, 2019).
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