PlainRecalls

Helena Laboratories, Inc.

Compiled from official public sources by the publisher.

5 recalls on record · Latest: Sep 11, 2019

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Agency notice ledger

Federal filing book Helena Laboratories, Inc. LIGHT-BOOK · SINGLE-AGENCY

#2,492 of 14,151 · 5 notices · 0.005% archive

  • BOOK 5 notices
  • RANK #2,492 of 14,151
  • SHARE 0.005% archive
  • AGENCY FDA Devices (5)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 11, 2019
  • PHOTO A G Specialty Foods I…

Nearest notice-volume peer: A G Specialty Foods Inc (0 notice gap)

Helena Laboratories, Inc. accounts for about 0.005% of the 104,423-notice archive on 5 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 →

Helena Laboratories, Inc.'s standing among 14,151 recalling firms

Helena Laboratories, Inc. ranks 2,492nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Helena Laboratories, Inc. vs all firms by recall-notice count

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

5 2492nd of 14151 higher than 11,411 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

Helena Laboratories, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Helena Laboratories, Inc. holds about 0.005% of archive notices alongside 5 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 11, 2019

Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
FDA Devices Moderate Dec 19, 2018

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
FDA Devices Low Dec 12, 2018

Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.
FDA Devices Moderate Dec 12, 2018

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
FDA Devices Moderate Oct 24, 2018

"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Out

Helena Laboratories, Inc. is a small archive contributor

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

Frequently Asked Questions

How many federal recall notices name Helena Laboratories, Inc.? ▼
PlainRecalls indexes 5 distinct federal recall events naming Helena Laboratories, Inc., 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 Helena Laboratories, Inc. sit among other recalling firms? ▼
Helena Laboratories, Inc. ranks #2,492 of 14,151 by distinct recall-event count among 14,151 firms in this archive (81st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Helena Laboratories, Inc.'s notices? ▼
FDA Devices accounts for 5 of this firm's 5 indexed notices.
What product category dominates Helena Laboratories, Inc.'s filing book? ▼
Filings for Helena Laboratories, Inc. 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.
Helena Laboratories, Inc.: 5 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 Helena Laboratories, Inc.; individual notices remain authoritative on each linked recall page.

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