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Terminated

InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

FDA Recall Z-2113-2014 · Posted 2014-07-24

Recalling FirmBiogenex Laboratories, Inc.
Recall StatusTerminated
Product CodeMVC
Date Initiated2014-07-01
Date Terminated2014-07-24
Product Quantity4 kits

Reason for Recall

Product was distributed without 510(k) approval.

Firm Action

Each customer contacted by phone - neither is in possession of the product.

Root Cause

No Marketing Application

Distribution Pattern

Brazil and Ecuador. No US distribution

Official Source

View FDA Recall →

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

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