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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · Life Technologies Corporation
See all →- HighTorrent Suite Dx Software versions affected by cybersecurity vulnerability
FDA (Devices) · 2024-04-10
- HighLife Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
FDA (Devices) · 2020-09-23
- HighLife Technologies Recalls TaqPath RT-PCR COVID-19 Kit Software
FDA (Devices) · 2020-09-23
- ModerateLife Technologies Recalls Oncomine Dx Target Test DNA Control-IVD
FDA (Devices) · 2020-04-22
- ModerateLife Technologies Recalls Oncomine Dx Target Test RNA Control for Expiration Date Error
FDA (Devices) · 2020-04-22
Same hazard · false positive
See all →- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- LowBion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date
FDA (Devices) · 2013-06-12
- HighAlinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results
FDA (Devices) · 2022-08-03
- HighDiagnostic Kit Recalled for False Positive Bacterial Identification Results
FDA (Devices) · 2022-12-07
- HighDxH 900 hematology analyzers recalled over erroneously high hemoglobin results
FDA (Devices) · 2025-09-24
- LowBion Enterprises IgM Conjugate Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2013-06-12
- HighHematology analyzers recalled over erroneously high hemoglobin results in some samples
FDA (Devices) · 2025-09-24