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U.S. Department of Health and Human Services

Class 2 Device Recall ZYMUTEST HIA IgGAM

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 Class 2 Device Recall ZYMUTEST HIA IgGAMsee related information
Date Initiated by FirmNovember 09, 2011
Date PostedMarch 15, 2018
Recall Status1 Terminated 3 on June 21, 2018
Recall NumberZ-1062-2018
Recall Event ID 79269
510(K)NumberK071255 
Product Classification Platelet factor 4 radioimmunoassay - Product Code LCO
ProductZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
Code Information UDI: 03663537018770 Lot Number: F1700415
Recalling Firm/
Manufacturer		 Hyphen BioMed
155 rue d Eragny
Neuville Sur Oise France
Manufacturer Reason
for Recall		A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
FDA Determined
Cause 2		Other
ActionThe manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to: 1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993.
Quantity in Commerce94
DistributionWorldwide Distribution - US Distribution and to the countries of : Austria and France.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LCO
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