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Terminated

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

FDA Recall Z-2382-2021 · Posted None

Recalling FirmThera Test Laboratories, Inc.
Recall StatusTerminated
Product CodeQKO
Date Initiated2020-10-05
Date Terminated2022-02-15
Product Quantity19 kits

Reason for Recall

The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128

Firm Action

The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.

Official Source

View FDA Recall →

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

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