PlainRecalls

Sekisui Diagnostics LLC

Compiled from official public sources by the publisher.

4 recalls on record · Latest: Oct 23, 2013

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Agency notice ledger

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

#3,173 of 14,151 · 4 notices · 0.004% archive

  • BOOK 4 notices
  • RANK #3,173 of 14,151
  • SHARE 0.004% archive
  • AGENCY FDA Devices (4)
  • CAT medical devices
  • CATS 1 category
  • LATEST Oct 23, 2013
  • PHOTO 1 Epic, LLC

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

Sekisui 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 →

Where Sekisui Diagnostics LLC sits among 14,151 recalling firms

Sekisui Diagnostics LLC ranks 3,173rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Sekisui Diagnostics LLC vs all firms by recall-notice count

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

4 3173rd 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 · 2026-09-13

Sekisui Diagnostics LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Sekisui 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 Oct 23, 2013

Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An

FDA Devices Moderate Dec 12, 2012

Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
FDA Devices Moderate Sep 26, 2012

Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
FDA Devices Moderate Jul 4, 2012

MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.

Sekisui 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 Sekisui Diagnostics LLC? ▼
PlainRecalls indexes 4 distinct federal recall events naming Sekisui 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 Sekisui Diagnostics LLC sit among other recalling firms? ▼
Sekisui Diagnostics LLC ranks #3,173 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 Sekisui Diagnostics LLC's notices? ▼
FDA Devices accounts for 4 of this firm's 4 indexed notices.
What product category dominates Sekisui Diagnostics LLC's filing book? ▼
Filings for Sekisui 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.
Sekisui 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 Sekisui Diagnostics LLC; individual notices remain authoritative on each linked recall page.

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