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U.S. Department of Health and Human Services

Class 2 Device Recall ZYMUTEST HIA IgGAM ELISA

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  Class 2 Device Recall ZYMUTEST HIA IgGAM ELISA see related information
Date Initiated by Firm February 05, 2018
Create Date May 08, 2018
Recall Status1 Terminated 3 on August 16, 2018
Recall Number Z-1744-2018
Recall Event ID 79797
510(K)Number K071255  
Product Classification Platelet factor 4 radioimmunoassay - Product Code LCO
Product ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
Code Information Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
Recalling Firm/
Manufacturer		 Hyphen BioMed
155 rue d Eragny
Neuville Sur Oise France
Manufacturer Reason
for Recall		 Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
FDA Determined
Cause 2		 Packaging process control
Action On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at Sandra@aniara.com or by phone at (866)783-3797 ext. 110.
Quantity in Commerce 281
Distribution OH, MD, NC, NY, NH, Canada, Sweden
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 = LCO and Original Applicant = HYPHEN BIOMED
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