Life Technologies Corporation: Medical Device Recall in 2018 - (Recall #: Z-1388-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Product Classification:

Class II

Date Initiated: February 7, 2018

Date Posted: April 25, 2018

Recall Number: Z-1388-2018

Event ID: 79603

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)

Status: Terminated

Product Quantity:

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

Voluntary or Mandated:

Voluntary: Firm initiated