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
|