FDA Device recall Z-1388-2018
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Human Fetal Hemoglobin (HBF-1) FITC Conjugate by Life Technologies, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1388-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-07 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Life Technologies |
| Distribution | CA, DE, FL, IL, IN, MA, MI, MN, NJ, NY, OR, PA, SC, TX, WA |
Product
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Reason
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)
Identifiers
| code_info | Model # MHFH01 UDI (01)10190302005579(17)180430 (10)1626670D(240)MHFH01 Lot# 1626670D Model #…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1388-2018%22
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