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U.S. Department of Health and Human Services

Class 2 Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0

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 Class 2 Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0see related information
Date Initiated by FirmNovember 10, 2017
Create DateMarch 07, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0924-2018
Recall Event ID 79181
510(K)NumberK023889 
Product Classification Enzyme linked immunosorbent assay, t. Cruzi - Product Code MIU
ProductWiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Code Information Product Code 1293254, Lot Code 1709228140
FEI Number 3001026625
Recalling Firm/
Manufacturer		 Wiener Laboratories
Street
Riobamba Argentina
For Additional Information Contact
757-224-0177
Manufacturer Reason
for Recall		Internal program testing shows that product may not reach the indicated expiration date.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn about November 10, 2017, customers were notified via email of the recall. Instructions include to examine inventory and cease distribution of the device, make arrangements to return affected devices, acknowledge receipt of the recall notification, and notify customers if further distributed.
Quantity in Commerce1,563 units
DistributionWorldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MIU
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