Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Serrated Blade Applicator Kit (12 Sample) Recalled by Helena Laboratories, Corp. Due to Packaging for a serrated blade applicator kit (12...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.
Affected Products
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Quantity: 32 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 8 states: AR, CA, FL, MI, NE, NY, PA, TX
About Helena Laboratories, Corp.
Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report