Helena Laboratories, Corp. recalls
Every recall we track for Helena Laboratories, Corp. — 11 in all, from 2017–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Helena Laboratories, Corp. peaked in 2018 (5); 11 since 2017.
All FDA recall records for Helena Laboratories, Corp. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 0 | 0 | 5 | 0 | 5 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Helena Laboratories, Corp. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Helena Laboratories, Corp. recalls
9 shown- Lower riskMedical device
Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade
Helena Laboratories recalls serrated blade applicator kits for incorrect or delayed lab results due to missing samples. Affected kits may need replacement to ensure accurate testing.
Helena LaboratoriesMay 2, 2023 - Lower riskMedical device
Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803
Helena Laboratories recalls V8 Immunodisplacement Kit REF 1803 due to microbial growth interfering with test results. Affected units have specific model and lot numbers.
Helena LaboratoriesApr 6, 2022 - Lower riskMedical device
Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the
Helena Laboratories recalls Cascade Abrazo aPTT Test Cards (Model 5722) due to intermittent shorter clot times. Affected lots expire by Dec 2021. Contact for replacement.
Helena LaboratoriesJan 5, 2021 - Lower riskMedical device
Helena Laboratories, Corp. recalls K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE
Helena Laboratories recalls K-ACT Actaly: Cracked test tube caps may cause leaks or contamination during blood tests. Affected lots 1-19-K-ACT and 2-19-K-ACT.
Helena LaboratoriesNov 9, 2020 - Lower riskMedical device
Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena
Helena Laboratories recalls ColoCARE diagnostic kits with faulty positive control that may not react properly during testing. Affected kits have specific lot numbers and expiration dates.
HelenaAug 8, 2018 - Lower riskMedical device
Helena Laboratories, Corp. recalls Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent
Helena Laboratories recalls Platelet Aggregation Kit Cat. No. 5369 due to potential particulate matter or microbial growth in collagen vials. Affected units may pose contamination risks during lab studies.
Helena LaboratoriesMay 23, 2018 - Lower riskMedical device
Helena Laboratories, Corp. recalls SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose
Helena Laboratories recalls SPIFE Alkaline Hemoglobin Kit (Cat. No. 3415) due to outdated instructions that could lead to incorrect results. Affected lots include specific 2017 and 2018 production batches with expiration dates up to December 31, 2018.
Helena LaboratoriesFeb 27, 2018 - Lower riskMedical device
Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories,
Helena Laboratories recalls export-only Cascade Abrazo aPTT Test Card Model 5722 due to potential false negatives from shorter clot times. Affected units sold with lot 2-17-5722 expiring 2018-09-30.
Helena LaboratoriesDec 7, 2017 - Lower riskMedical device
Helena Laboratories, Corp. recalls SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena
Helena Laboratories recalls SPIFE ImmunoFix-6 diagnostic kits with missing control wells that could lead to inaccurate test results. Affected kits have specific lot numbers and expiration dates.
HelenaJul 21, 2017
Helena Laboratories, Corp. recall questions
How many recalls has Helena Laboratories, Corp. had?
11 recalls from Helena Laboratories, Corp. are on record with U.S. safety agencies, from 2017–2023.
What is the most recent Helena Laboratories, Corp. recall?
Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade, dated May 2, 2023. Every Helena Laboratories, Corp. recall is listed on this page, newest first.
What should I do if I have a recalled Helena Laboratories, Corp. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Helena Laboratories, Corp. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.