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Open, Classified

Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

FDA Recall Z-0920-2022 · Posted None

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodeNSU
Date Initiated2019-04-22
Product Quantity4 units

Reason for Recall

Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

Firm Action

The firm sent technicians to sites beginning on 13 March 2019 to test the devices and the devices were subsequently returned. The firm send a notice regarding the recall on 03/10/2022 by email. The notices documented the actions of the firm with respect to the devices.

Root Cause

Under Investigation by firm

Distribution Pattern

US: TX, CT, LA

Official Source

View FDA Recall →

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

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