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Thera Test Laboratories, Inc. Recall 88478

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

Thera Test Laboratories, Inc. Recall 88478 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-2382-2021
Event ID88478
Event DescriptionEL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Product TypeDevices
DistributionUS Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Quantity19 kits
Recall ReasonThe cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Device Classification20210908
Device Code InfoLot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Center Classification Date20210827
Recall Initiation Date20201005
Recalling FirmThera Test Laboratories, Inc.
Initial Notification Letter
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