Food, drugs, devices › Polymer Technology Systems, Inc.
Device recall: PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system
FDA enforcement event 84840 is a device recall by Polymer Technology Systems, Inc. of Indianapolis, IN, initiated 21 Jan 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 14 Dec 2020. Initiation: voluntary: firm initiated. Polymer Technology Systems, Inc. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Polymer Technology Systems, Inc., Indianapolis, IN.
Reason for recall
"The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance."
Distribution
"Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1438-2020 | 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… | 6790 | Class II | Terminated | 11 Mar 2020 |
Context
Other enforcement events for Polymer Technology Systems, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Dec 2019 | PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 | Device | Class II | 4 |
| 7 Jun 2019 | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel te | Device | Class III | 2 |
| 16 Jan 2019 | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 | Device | Class II | 3 |
| 14 Mar 2018 | PTS Panels¿ CHOL+GLU Test Strips (REF 1765) | Device | Class II | 1 |
| 15 Mar 2016 | PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers | Device | Class II | 1 |
| 4 Apr 2013 | PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals | Device | Class II | 1 |
| 15 May 2012 | PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. | Device | Class II | 1 |
All 8 events for Polymer Technology Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.