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Open, Classified

Verigene EP Amplification Reagent Kit Test

FDA Recall Z-2451-2021 · Posted None

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodePCH
Date Initiated2021-08-03
Product Quantity4579 kits

Reason for Recall

There is potential for false positive results.

Firm Action

A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.

Official Source

View FDA Recall →

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

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