Reported Mar 11, 2020 · Terminated
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine…
Polymer Technology Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymer Technology Systems, Inc. · 7736 Zionsville Rd · Indianapolis, IN · 46268-2175
Is this the product you have?
PTS Detect CotinineRef. No. 3061UPC 381933061017
- in vitro diagnostic - Product UsageThe PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine
- Lot codes and dates
- 1811715 1831313 1831324 1831325
- Amount recalled
- 6790
Where it was sold
- Nationwide
Why it was recalled
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
This product could cause temporary or reversible health problems — stop using it.
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