FDAClass IIMarch 14, 2018

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 recall

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Why was Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 recalled?

Internal program testing shows that product may not reach the indicated expiration date.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code 1293254, Lot Code 1709228140

Product
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Recalling firm
Wiener Laboratories
Quantity
1,563 units
Distribution
Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
Recall date
March 14, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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