Kreatech recalls PapV-16 HPV-16 DNA probes due to potential false positive/negative results from suboptimal hybridization in specific lots. Affected units include Model 40V016V495 with Lot Number 00088454.
The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.
Kreatech is recalling its PapV-16 HPV-16 DNA probe for false results. If users don't use proper controls, they might think they have HPV-16 when they don't or miss it entirely.
The DNA fragments in this specific lot are too large, causing background noise during testing. This can make the probe show false positives (indicating HPV-16 when it's not present) or false negatives (missing HPV-16 when it is present) if proper controls aren't used.
Users of the Kreatech PapV-16 probe for HPV-16 DNA testing are affected. Those who rely on the probe without proper controls are most at risk of incorrect results.
Check for Model Number 40V016V495 and Lot Number 00088454 on the probe packaging. The recall applies to specific lots of this probe used for HPV-16 DNA detection.
Look for Model Number 40V016V495 and Lot Number 00088454 on the probe packaging to confirm if it's affected.
The DNA fragments in this specific lot are too large, causing potential false positive or false negative results if proper controls aren't used.
Check the model and lot number on the packaging. If it matches Model 40V016V495 and Lot 00088454, contact Kreatech for guidance.
The probe can be used safely if proper positive and negative controls are included during testing, but it may give incorrect results without them.
We’ve drafted a message you can send Kreatech to request your refund or repair — edit it as you like.
Subject: Recall Z-0522-2025 — Kreatech Kreatech Hello, I own a Kreatech that is covered by recall Z-0522-2025 from Kreatech. 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.
