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U.S. Department of Health and Human Services

Class 2 Device Recall ZYMUTEST HIA MonoStrip IgG

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  Class 2 Device Recall ZYMUTEST HIA MonoStrip IgG see related information
Date Initiated by Firm July 19, 2019
Create Date August 22, 2019
Recall Status1 Terminated 3 on June 11, 2021
Recall Number Z-2346-2019
Recall Event ID 83487
510(K)Number K071255  
Product Classification Platelet factor 4 radioimmunoassay - Product Code LCO
Product ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Code Information F1701084, F1900611
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information Contact Colleen Murphy
513-360-6377
Manufacturer Reason
for Recall		 Residual crystallization of the microplate and recurrent negative controls out of range.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified customers of the recall via Urgent Medical Device Correction emails dated July 26, 2019. Customers were informed of the recall and asked to destroy the affected kits in stock and indicate the quantity in the Awareness Acknowledgement Form, which was to be signed and returned to the local distributor. If you have any questions regarding this recall, please contact Aniara at (513) 360-6377, or CMurphy@aniara.com.
Quantity in Commerce 51
Distribution Distribution to US states of NC, NH, NY, and OH, and 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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