CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Human Fetal Hemoglobin (Hbf-1) Fitc Conjugate recalled
Life Technologies is recalling Human Fetal Hemoglobin (Hbf-1) Fitc Conjugate, distributed in 15 states. The recall was initiated on 7 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1388-2018
- FDA event ID
- 79603
- Recalling firm
- Life Technologies, Frederick, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Feb 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +69 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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)
Product as listed by the FDA
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Where it was distributed
MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
CaliforniaDelawareFloridaIllinoisIndianaMassachusettsMichiganMinnesotaNew JerseyNew YorkOregonPennsylvaniaSouth CarolinaTexasWashington
Questions about this recall
Why was it 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)
Which lots are affected?
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
Where was it sold?
MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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