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Class 2 Device Recall ELAntiSARSCoV2 IgM Kit |
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| Date Initiated by Firm |
July 30, 2020 |
| Create Date |
August 27, 2021 |
| Recall Status1 |
Terminated 3 on February 15, 2022 |
| Recall Number |
Z-2381-2021 |
| Recall Event ID |
88477 |
| Product Classification |
Reagent, coronavirus serological - Product Code QKO
|
| Product |
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 |
| Code Information |
Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021. |
Recalling Firm/
Manufacturer |
Thera Test Laboratories, Inc.
1120 N Du Page Ave
Lombard IL 60148-1247
|
| For Additional Information Contact |
Mr. Anthony Tate
630-627-6069 Ext. 241
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Manufacturer Reason
for Recall |
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
|
FDA Determined
Cause 2 |
No Marketing Application |
| 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. |
| Quantity in Commerce |
11 kits |
| Distribution |
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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