Human Fetal Hemoglobin (HBF-1) FITC Conjugate recallZ-1388-2018 · Life Technologies Corporation · initiated Feb 7, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Life Technologies Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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)
FDA root cause category: Use error
What the company is doing
All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure. The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions.
Recall details
- Recall number
- Z-1388-2018
- Status
- Terminated
- Initiated by the company
- Feb 7, 2018
- Recalling firm
- Life Technologies Corporation
- Product code
- GHQ
- FDA submissions
- K990641
- Distribution
- MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
Product description
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Human Fetal Hemoglobin FITC Conjugate MHFH01Life Technologies Corporation · STAIN, FETAL HEMOGLOBIN1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page