FDA
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
Diagnosis of Chagas disease.
Internal program testing shows that product may not reach the indicated expiration date.
On 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.