FDA Medical Device Recalls (openFDA)
Wiener Laboratories: Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
- Recall number
- Z-0924-2018
- Recalling firm
- Wiener Laboratories
- Product
- Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
- Status
- Open, Classified
- Initiated
- 2017-11-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- Internal program testing shows that product may not reach the indicated expiration date.
- 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
- 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.
- Lot, serial or model codes
- Product Code 1293254, Lot Code 1709228140
- 510(k) numbers
- ["K023889"]
- PMA numbers
- not on file
- Product code
- MIU
- Firm FEI
- 3001026625
- Firm city
- Riobamba
- Firm state
- not on file
- Firm country
- Argentina
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28