Z-0924-2018 Class II Ongoing
FDA device recall Z-0924-2018 was initiated by Wiener Laboratories on November 10, 2017 and is designated Class II. Reason for recall: Internal program testing shows that product may not reach the indicated expiration date. The recall status is ongoing. Affected quantity: 1,563 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- November 10, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,563 units
Product Description
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 Pattern
Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
Code Information
Product Code 1293254, Lot Code 1709228140