Z-0924-2018Class II

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

Name: Z-0924-2018 Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease
Creator: Wiener Laboratories
Published: 2017-11-10
License: https://open.fda.gov/license/

Wiener Laboratories / initiated 2017-11-10 / Open, Classified / root cause: manufacturing process

FDA source

Wiener Laboratories began a recall of Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease on 2017-11-10. FDA classified it as Class II and gives the reason as "Internal program testing shows that product may not reach the indicated expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0924-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-11-10
Posted: 2018-03-07
Recalling firm: Wiener Laboratories
Product: Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Product code: MIU Enzyme Linked Immunosorbent Assay, T. Cruzi
Reason for recall: Internal program testing shows that product may not reach the indicated expiration date.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 1,563 units
Distribution: Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
Product codes and lots: Product Code 1293254, Lot Code 1709228140

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0924-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0924-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-03-14	2018-03-07

Product code MIU

K023889Class IWiener Lab. Chagatest Elisa Recomninante V.3.0, Model 96 Tests Cat. Nr. 1203254Wiener Laboratories Saic / cleared 2004-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)