EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Summary
The FDA issued a Class II for EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 by Thera Test Laboratories, Inc.. Reason: The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128.
Details
Source
Device Recall
External ID
Z-2382-2021
Action Date
2021-09-08
Status
Terminated
Category
device
Product Description
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Lot/Code Info: Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Quantity Affected: 19 kits
Reason for Recall
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Distribution
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-10-05
Company
Lombard, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 126 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Thera Test Laboratories, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thera Test Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thera Test Laboratories, Inc. have FDA actions?
Thera Test Laboratories, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2382-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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