Human Fetal Hemoglobin — Class II medical device recall Z-1388-2018
Terminated recall by Life Technologies Corporation, reported 2018-04-25, distributed in CA, DE, FL, IL, IN, MA, MI, MN…. Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining
| Recall number | Z-1388-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Life Technologies Corporation, Frederick, MD, United States |
| Recall initiated | 2018-02-07 |
| Classified | 2018-04-17 |
| Reported by FDA | 2018-04-25 |
| Terminated | 2019-05-08 |
| Distributed | CA, DE, FL, IL, IN, MA, MI, MN, NJ, NY, OR, PA, SC, TX, WA |
| UPC / GTIN / UDI-DI | 10190302005579 |
| Lot numbers | 1626670D, 1873068B, 1915224B |
| Model numbers | MHFH01 |
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1388-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.