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Helena Laboratories, Corp.

Helena Laboratories, Corp. Recalls

All product recalls associated with Helena Laboratories, Corp..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Helena Laboratories, Corp.: Serrated Blade Applicator Kit (12 Sample), REF: 552687, F...

Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.

FDAMay 2, 2023AR, CA, FL +5 more• Helena Laboratories, Corp.

Helena Laboratories, Corp.: V8 Immunodisplacement Kit REF 1803

Due to microbial growth causing interference with interpretation.

FDAApr 6, 2022FL, MO, OH +1 more• Helena Laboratories, Corp.

Helena Laboratories, Corp.: Cascade Abrazo aPTT Test Card - Product Usage: are to be ...

Intermittent potential for shorter than expected clot times.

FDAJan 5, 2021Nationwide

• Helena Laboratories, Corp.

Helena Laboratories, Corp.: K-ACT Actalyke Clotting Test Tubes that are used in the: ...

Due to complaints received associated with cracked/split test tube caps.

FDANov 9, 2020Nationwide• Helena Laboratories, Corp.