CLASS II ONGOING Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
Wiener Lab Chagatest Elisa Recombinante V recalled
Wiener Laboratories is recalling Wiener Lab Chagatest Elisa Recombinante V. 3.0 Diagnosis of Chagas disease, distributed in District of Columbia, Florida, Washington. The recall was initiated on 10 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0924-2018
- FDA event ID
- 79181
- Recalling firm
- Wiener Laboratories, Riobamba, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Nov 2017
- FDA classified
- 7 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2017 | Recall initiated by company | |
| 7 Mar 2018 | Classified by FDA | +117 days |
| 14 Mar 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Internal program testing shows that product may not reach the indicated expiration date.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Where it was distributed
Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
Questions about this recall
Why was it recalled?
Internal program testing shows that product may not reach the indicated expiration date.
Which lots are affected?
Product Code 1293254, Lot Code 1709228140
Where was it sold?
Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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