Wiener Laboratories: Medical Device Recall in 2018 - (Recall #: Z-0924-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 10, 2017

Date Posted: March 14, 2018

Recall Number: Z-0924-2018

Event ID: 79181

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,563 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated