Life Technologies Recalls Human Fetal Hemoglobin FITC Conjugate Due to Staining Issues
Life Technologies is recalling three lots of Human Fetal Hemoglobin FITC Conjugate because high background and unusual staining may cause false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential false positive results in medical testing, which is a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Life Technologies Corporation is recalling three lots of Human Fetal Hemoglobin (HBF-1) FITC Conjugate. The affected product is identified by Model # MHFH01 and specific lot numbers 1626670D, 1873068B, and 1915224B.
The recall was initiated because the product is displaying high background and unusual bright staining in controls and patient samples. This defect could potentially lead to erroneous results, specifically false positives, in laboratory testing.
The affected units were distributed to facilities in Michigan, California, Illinois, Texas, South Carolina, New York, Minnesota, Delaware, New Jersey, Washington, Oregon, Indiana, Massachusetts, and Florida. Users of this product should stop using the affected lots and contact Life Technologies Corporation for further instructions.
The recalled product
- Product
- Human Fetal Hemoglobin (HBF-1) FITC Conjugate
- Manufacturer
- Life Technologies Corporation
Distribution
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