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U.S. Department of Health and Human Services

Class 2 Device Recall Human Fetal Hemoglobin (HBF1) FITC Conjugate

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  Class 2 Device Recall Human Fetal Hemoglobin (HBF1) FITC Conjugate see related information
Date Initiated by Firm February 07, 2018
Create Date April 17, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-1388-2018
Recall Event ID 79603
510(K)Number K990641  
Product Classification Stain, fetal hemoglobin - Product Code GHQ
Product Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Code Information 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
Recalling Firm/
Manufacturer		 Life Technologies Corporation
7335 Executive Way
Frederick MD 21704-8354
For Additional Information Contact Joy Bickle
858-202-6038
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GHQ and Original Applicant = CALTAG LABORATORIES, INC.
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