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Open, Classified

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

FDA Recall Z-0924-2018 · Posted None

Recalling FirmWiener Laboratories
Recall StatusOpen, Classified
Product CodeMIU
Date Initiated2017-11-10
Product Quantity1,563 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254Wiener Laboratories Saic · 2004-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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