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Recall Observatory FDA recall evidence

Device product

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

Z-0924-2018

November 10, 2017

Class II

Product summary

Firm
Wiener Laboratories
Event
Event 79181
Status
Ongoing
Classification
Class II
Quantity
1,563 units
Official record key
device-enforcement:Z-0924-2018

Official wording

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

Code information: Product Code 1293254, Lot Code 1709228140

Distribution pattern: Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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