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Thera Test Laboratories, Inc. Recall 88477

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

Thera Test Laboratories, Inc. Recall 88477 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2381-2021
Event ID88477
Event DescriptionEL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Quantity11 kits
Recall ReasonDevice did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Device Classification20210908
Device Code InfoKit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.
Center Classification Date20210827
Recall Initiation Date20200730
Recalling FirmThera Test Laboratories, Inc.
Initial Notification Letter
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