Z-2409-2021Class II

Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and...

Name: Z-2409-2021 Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and...
Creator: Versea Diagnostics LLC
Published: 2021-07-27
License: https://open.fda.gov/license/

Versea Diagnostics LLC / initiated 2021-07-27 / Terminated / root cause: manufacturing process

FDA source

Versea Diagnostics LLC began a recall of Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2... on 2021-07-27. FDA classified it as Class II and gives the reason as "Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2409-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-27
Posted: 2021-09-03
Terminated: 2024-04-10
Recalling firm: Versea Diagnostics LLC
Product: Healgen 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
Product code: QKO Reagent, Coronavirus Serological
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Versea 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: [email protected]. 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 [email protected]. We are available Monday through Friday from 8:00 AM to 4:00 PM Eastern Time.
Quantity in commerce: 563,290 in total
Distribution: US 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.
Product codes and lots: all lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2409-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2407-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02
Z-2408-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02
Z-2409-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02
Z-2410-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)