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[Recalled] Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. — Internal program testing shows that product may not reach the indicated expirat… | FDA 2017-11-10

recall fda device argentina

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductWiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Brand / manufacturerWiener Laboratories
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0924-2018
Country of noticeArgentina
Risk levelClass II
Hazard typerecall
Notice date10 November 2017
EAN / barcode1709228140

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Internal program testing shows that product may not reach the indicated expiration date.

This Class II recall concerns device products distributed in Argentina and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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