Date Initiated by Firm |
November 09, 2011 |
Date Posted |
March 15, 2018 |
Recall Status1 |
Terminated 3 on June 21, 2018 |
Recall Number |
Z-1062-2018 |
Recall Event ID |
79269 |
510(K)Number |
K071255
|
Product Classification |
Platelet factor 4 radioimmunoassay - Product Code LCO
|
Product |
ZYMUTEST 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 |
Action |
The 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 Commerce |
94 |
Distribution |
Worldwide Distribution - US Distribution and to the countries of : Austria and France. |
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
|