Date Initiated by Firm | July 19, 2019 |
Create Date | August 22, 2019 |
Recall Status1 |
Terminated 3 on June 11, 2021 |
Recall Number | Z-2347-2019 |
Recall Event ID |
83487 |
510(K)Number | K071255 |
Product Classification |
Platelet factor 4 radioimmunoassay - Product Code LCO
|
Product | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. |
Code Information |
F1701571 |
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 | 46 |
Distribution | Distribution to US states of NC, NH, NY, and OH, and 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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