Polymer Technology Systems recalls PTS Detect Cotinine (Ref. 3061, UPC 381933061017) due to lack of FDA 510(k) clearance for professional use. The product is no longer available in the market.
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Polymer Technology Systems is recalling their PTS Detect Cotinine test kit because it hasn't been cleared by the FDA for professional use. This means the product is no longer available and should not be used.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for professional use. This could lead to inaccurate results if used without proper regulatory oversight.
Healthcare professionals who use this test kit for nicotine exposure screening may be affected. The risk is low since the product is no longer available.
Check for the product name 'PTS Detect Cotinine', reference number 3061, and UPC 381933061017. The product was sold for professional use to determine nicotine exposure.
The product is no longer available in the market and should not be used.
The product lacks FDA 510(k) clearance for professional use, so it was removed from the market.
No, the product is no longer available and should not be used due to lack of FDA clearance.
Look for the product name 'PTS Detect Cotinine', reference number 3061, and UPC 381933061017.
We’ve drafted a message you can send Polymer Technology Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1438-2020 — Polymer Technology Systems Polymer Technology Systems Hello, I own a Polymer Technology Systems that is covered by recall Z-1438-2020 from Polymer Technology Systems. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
