Date Initiated by Firm | February 05, 2018 |
Create Date | May 08, 2018 |
Recall Status1 |
Terminated 3 on August 16, 2018 |
Recall Number | Z-1743-2018 |
Recall Event ID |
79797 |
510(K)Number | K071255 |
Product Classification |
Platelet factor 4 radioimmunoassay - Product Code LCO
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Product | ZYMUTEST HIA MonoStria 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. p IgGAM; REF Number: RK041D; UDI: 03663537046810 |
Code Information |
Lot numbers: F1600568P1, F1701370P1, F1701370P2 |
Recalling Firm/ Manufacturer |
Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France
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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 | 60 |
Distribution | OH, MD, NC, NY, NH, Canada, Sweden |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LCO
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