Lower riskMedical device recall · FDA · Published February 7, 2018
Life Technologies Recalls HBF-1 FITC Conjugate for False Positive Results
Life Technologies recalls three lots of Human Fetal Hemoglobin FITC Conjugate due to potential false positives in tests. Affected units may cause incorrect results in patient samples and controls.
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)
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Contact the company
📍Recalling firmLife Technologies Corporation7335 Executive Way · Frederick, MD 21704-8354
✎ GovInfoNow plain-language explainer
Life Technologies is recalling three specific lots of Human Fetal Hemoglobin FITC Conjugate because they can cause false positive results in tests. This means the product might give incorrect results for patient samples and controls, which could lead to wrong medical conclusions. Read more at govinfonow.com/recall/72032-life-technologies-recalls-hbf-1-fitc-conjugate-for-false-positive.
“Life Technologies Recalls HBF-1 FITC Conjugate for False Positive Results.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72032-life-technologies-recalls-hbf-1-fitc-conjugate-for-false-positive. Based on FDA recall #Z-1388-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1388-2018%22&limit=1).
The FDA announced on Feb. 7, 2018, that Life Technologies Corporation voluntarily recalled Human Fetal Hemoglobin (HBF-1) FITC Conjugate due to a Class II hazard. The product may display high background and unusual bright staining, potentially leading to erroneous results such as false positives.
How to tell if you have it
Brand: Life Technologies
Product: Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Model #: MHFH01
UPC: 10190302005579
Lot codes: 1626670D, 1873068B, 1915224B
The hazard
Three lots of the conjugate are displaying high background and unusual bright staining in controls and patient samples. This defect could potentially lead to erroneous results, specifically false positives.
Context
GovInfoNow's records show Life Technologies Corporation has had six other recalls on record since Dec. 4, 2017. Other recent recalls of similar products include Life Technologies Torrent Suite Dx Software 5.14 (Feb. 7, 2024), Life Technologies COVID-19 Test Software (Aug. 6, 2020), and Life Technologies Oncomine DNA Control (March 16, 2020). Other recent recalls of similar products include Exploro Fertility Test (Nov. 22, 2025), Siemens Atellica CH A1c_E Test (June 8, 2026), and Vivoo Protein Test (Nov. 22, 2025).
How to tell if you have this one
Check the lot numbers: 1626670D, 1873068B, and 1915224B. The product is labeled as Human Fetal Hemoglobin (HBF-1) FITC Conjugate with model number MHFH01.
Brand
Life Technologies
Product
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot numbers 1626670D, 1873068B, or 1915224B on the product label.
Where it went and when
Where it was distributed
Distributed in 15 states.
Listed by the agency
Not listed
FDA distribution: “MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Delaware, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1388-2018 (February 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1388-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.