Helena Laboratories recalls V8 Immunodisplacement Kit REF 1803 due to microbial growth interfering with test results. Affected units have specific model and lot numbers.
Due to microbial growth causing interference with interpretation.
Helena Laboratories is recalling its V8 Immunodisplacement Kit REF 1803 because microbial growth can cause inaccurate test results. This affects lab users who rely on the kit for precise interpretations.
Microbial growth in the kit can interfere with test interpretation, leading to inaccurate results. This does not pose a physical danger but affects the reliability of lab tests.
Lab users who purchased the V8 Immunodisplacement Kit REF 1803 are most at risk. The recall targets specific model and lot numbers sold between 2021 and 2022.
Check for model number 1803 and lot numbers 3-21-1803 or 1-22-1803. The kit was sold with specific UDI codes starting with M52518030.
Verify the model number (1803) and lot numbers (3-21-1803 or 1-22-1803) to confirm if your kit is affected.
No, the recall is for potential inaccurate test results due to microbial growth, not a physical hazard.
Check for model number 1803 and lot numbers 3-21-1803 or 1-22-1803 on the kit's label or documentation.
The recall does not require immediate action; check the kit details to confirm if it's affected.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2022 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-1244-2022 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.
