Z-1388-2018Class II

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Name: Z-1388-2018 Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Creator: Life Technologies Corporation
Published: 2018-02-07
License: https://open.fda.gov/license/

Life Technologies Corporation / initiated 2018-02-07 / Terminated

FDA source

Life Technologies Corporation began a recall of Human Fetal Hemoglobin (HBF-1) FITC Conjugate on 2018-02-07. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1388-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-07
Posted: 2018-04-17
Terminated: 2019-05-08
Recalling firm: Life Technologies Corporation
Product: Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Product code: GHQ Stain, Fetal Hemoglobin
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)
FDA root cause: Use error
Action: 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.
Distribution: MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1388-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1388-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code GHQ

K990641Class IICaltag Fetal Hemoglobin TestCaltag Laboratories, Inc. / cleared 1999-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)