Wiener Lab Chagas Disease Diagnostic Test Recalled for Expiration Concerns
Wiener Laboratories is recalling CHAGATEST ELISA RECOMBINANTE V. 3.0 diagnostic tests because internal testing suggests they may not reach their indicated expiration dates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard is a potential failure to reach the expiration date without reporting any illnesses, injuries, or adverse health consequences. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Wiener Laboratories is recalling 1,563 units of CHAGATEST ELISA RECOMBINANTE V. 3.0, a diagnostic test used for the diagnosis of Chagas disease. The recall was initiated because internal program testing indicates that the product may not reach the indicated expiration date.
The affected product is identified by Product Code 1293254 and Lot Code 1709228140. The recall covers worldwide distribution, including the United States (specifically Florida and Washington DC) and the countries of Argentina, Bolivia, Brasil, and Costa Rica.
Consumers and healthcare facilities should stop using the affected product and contact Wiener Laboratories for further instructions or a refund.
The recalled product
- Product
- Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
- Manufacturer
- Wiener Laboratories
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 1,563
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code 1293254
- Lot Code 1709228140
Distribution
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