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FDA (Device enforcement)Recalled 2018-02-07closedclass ii

Life Technologies Corporation: Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Is my product affected?

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

  • UPC 10190302005579

Check against the official notice below — it lists the full affected range.

What happened

Life Technologies Corporation has recalled three lots of Human Fetal Hemoglobin (HBF-1) FITC Conjugate due to a defect that causes high background staining and unusual bright staining in control and patient samples. This staining problem could lead to erroneous test results, including false positives. The affected lots are Lot# 1626670D, Lot# 1873068B, and Lot# 1915224B (Model # MHFH01), which were distributed across 16 states including Michigan, California, Illinois, Texas, New York, and others.

The recall notice does not specify a remedy or instructions for what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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)

Details from the source

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: MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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