Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
- Recall Initiated
- November 10, 2017
- Recall Number
- Z-0924-2018
- Quantity
- 1,563 units
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.
Lot / Code Info
Product Code 1293254, Lot Code 1709228140
Root Cause
Nonconforming Material/Component
Action Taken
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.