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Recall Observatory FDA recall evidence

Device product

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

Z-2381-2021

July 30, 2020

Class II

Product summary

Firm
Thera Test Laboratories, Inc.
Event
Event 88477
Status
Terminated
Classification
Class II
Quantity
11 kits
Official record key
device-enforcement:Z-2381-2021

Official wording

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

Code information: Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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