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Terminated

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

FDA Recall Z-2381-2021 · Posted None

Recalling FirmThera Test Laboratories, Inc.
Recall StatusTerminated
Product CodeQKO
Date Initiated2020-07-30
Date Terminated2022-02-15
Product Quantity11 kits

Reason for Recall

Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129

Firm Action

An undated letter was issued to their customers attached to an email dated 7/30/2020 explaining the reason for recall and requesting the customer stop testing with the kit.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.

Official Source

View FDA Recall →

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

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