# FDA recall Z-1388-2018

> **Life Technologies Corporation** · Class II · device recall initiated 2018-02-07.

## Product

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

## 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

## Key facts

- **Recall number:** Z-1388-2018
- **Recalling firm:** Life Technologies Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-04-25
- **Termination date:** 2019-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Frederick, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2018

## Citation

> AI Analytics. FDA recall Z-1388-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1388-2018. Source: US FDA. Licensed CC0.

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