CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
PTS Detect Cotinine recalled by Polymer Technology Systems
Polymer Technology Systems is recalling PTS Detect Cotinine, distributed nationwide in the US. The recall was initiated on 21 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1438-2020
- FDA event ID
- 84840
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2020
- FDA classified
- 4 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Jan 2020 | Recall initiated by company | |
| 4 Mar 2020 | Classified by FDA | +43 days |
| 11 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Product as listed by the FDA
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The 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.
Where it was distributed
Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Questions about this recall
Why was it recalled?
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Which lots are affected?
1811715 1831313 1831324 1831325
Where was it sold?
Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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