FDA recall Z-0924-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2017-11-10

Report date

2018-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Riobamba, N/A, Argentina

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0924-2018