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U.S. Department of Health and Human Services

Class 2 Device Recall Healgen COVID19 IgG/IgM Rapid Test Cassette

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 Class 2 Device Recall Healgen COVID19 IgG/IgM Rapid Test Cassettesee related information
Date Initiated by FirmJuly 27, 2021
Create DateSeptember 03, 2021
Recall Status1 Terminated 3 on April 10, 2024
Recall NumberZ-2409-2021
Recall Event ID 88429
Product Classification Reagent, coronavirus serological - Product Code QKO
ProductHealgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests
Code Information all lot codes
Recalling Firm/
Manufacturer		 Versea Diagnostics LLC
1000 N Florida Ave
Tampa FL 33602-3808
For Additional Information ContactStephen Porada
800-397-0670
Manufacturer Reason
for Recall		Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionVersea Diagnostics, LLC began distributing their "URGENT MEDICAL DEVICE RECALL" notices dated 7/14/2021 to their direct consignee on 7/27/2021 by email. The notices instructed the customers immediately discontinue use of these test and quarantine, discard, return, or destroy any unused tests. Confirm any results from these tests using a different EUA authorized test. Discontinue the use of these products if you do not hold the required CLLIA status. Acknowledge your receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: compliance@versea.com. VERSA Diagnostics, LLC will work with its Customers to either: Affirm their customers authorization to use these products through their CLIA Number and Status Coordinate the return of unused, unopened products to VERSA Diagnostics, LLC The distributors were directed to notify their customers. The firm is seeking return of unused products. If you have questions, please call 800-397-0670 or email us at compliance@versea.com. We are available Monday through Friday from 8:00 AM to 4:00 PM Eastern Time.
Quantity in Commerce563,290 in total
DistributionUS Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.
Total Product Life CycleTPLC Device Report
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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