PlainRecalls

Versea Diagnostics LLC

Compiled from official public sources by the publisher.

4 recalls on record · Latest: Sep 8, 2021

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Agency notice ledger

Federal filing book Versea Diagnostics LLC LIGHT-BOOK · SINGLE-AGENCY

#3,264 of 14,151 · 4 notices · 0.004% archive

  • BOOK 4 notices
  • RANK #3,264 of 14,151
  • SHARE 0.004% archive
  • AGENCY FDA Devices (4)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 8, 2021
  • PHOTO 1 Epic, LLC

Nearest notice-volume peer: 1 Epic, LLC (0 notice gap)

Versea Diagnostics LLC accounts for about 0.004% of the 104,423-notice archive on 4 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Versea Diagnostics LLC's standing among 14,151 recalling firms

Versea Diagnostics LLC ranks 3,264th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Versea Diagnostics LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

4 3264th of 14151 higher than 10,859 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-14

Versea Diagnostics LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Versea Diagnostics LLC holds about 0.004% of archive notices alongside 4 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 8, 2021

FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories)
FDA Devices Moderate Sep 8, 2021

Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency

FDA Devices Moderate Sep 8, 2021

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 certi
FDA Devices Moderate Sep 8, 2021

CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no mo

Versea Diagnostics LLC is a small archive contributor

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (4 here).

1 Epic, LLC 4 3rd Day Beverages LLC 4 A.p. Deauville, LLC 4 Aaa Pharmaceutical, Inc. 4 Aap Implantate Ag 4

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aap Implantate Ag 4 Ab Sciex, LLC 4 Accelerate Diagnostics Inc 4 Accord Media, LLC 4

Frequently Asked Questions

How many federal recall notices name Versea Diagnostics LLC? ▼
PlainRecalls indexes 4 distinct federal recall events naming Versea Diagnostics LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Versea Diagnostics LLC sit among other recalling firms? ▼
Versea Diagnostics LLC ranks #3,264 of 14,151 by distinct recall-event count among 14,151 firms in this archive (77th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Versea Diagnostics LLC's notices? ▼
FDA Devices accounts for 4 of this firm's 4 indexed notices.
What product category dominates Versea Diagnostics LLC's filing book? ▼
Filings for Versea Diagnostics LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Versea Diagnostics LLC: 4 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Versea Diagnostics LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026