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.
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.
Helena Laboratories is recalling a serrated blade applicator kit that can cause missed or light samples on gel, leading to incorrect or no test results. This affects lab users who rely on the Spife Nexus system for diagnostics.
The packaging may contain a serrated blade applicator that causes samples to be missed or appear light on the gel. This leads to incorrect or no results, potentially delaying accurate diagnoses.
Lab users who purchased the Serrated Blade Applicator Kit (12 Sample) with REF: 552687 for the Spife Nexus system are most at risk. This includes medical labs and researchers using in vitro diagnostics.
Check for the product name 'Serrated Blade Applicator Kit (12 Sample)', reference number 552687, and lot number 3-22. The kit is used with the Spife Nexus system for in vitro diagnostics.
Verify the reference number 552687 and lot number 3-22 on the packaging.
The packaging may contain a serrated blade applicator that causes missed or light samples on the gel, leading to incorrect or no test results.
The recall record does not specify a remedy, so check the product details to confirm if it's affected.
This recall is for potential incorrect test results, not physical harm. The hazard level is low risk.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1975-2023 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-1975-2023 from Helena Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
