Z-1438-2020Class II

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic -

Name: Z-1438-2020 PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic -
Creator: Polymer Technology Systems, Inc.
Published: 2020-01-21
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2020-01-21 / Terminated

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of... on 2020-01-21. FDA classified it as Class II and gives the reason as "The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1438-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Posted: 2020-02-20
Terminated: 2020-12-14
Recalling firm: Polymer Technology Systems
Product: 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.
Product code: MRS Test System, Nicotine, Cotinine, Metabolites
Reason for recall: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
FDA root cause: No Marketing Application
Action: The firm notified affected customers on January 21, 2020, via Urgent Medical Device Recall letter. The letter informed customers that the product had not received the necessary 510(k) clearance. Customers were asked to immediately segregate impacted product and hold for return to PTS Diagnostics. Distributors were asked to forward the notice and response form to all customers/users who may have received the product. All customers were asked to complete and return the attached acknowledgement form, even if they do not have affected product on hand. The firm's Customer Service team will contact customers upon receipt of the response form to arrange for return of the materials. If you have any questions regarding this recall, please contact the firm's Customer Service directly, Monday through Friday, 8AM-5PM EST, at +1 317-870-5610 or 877-870-5610 (toll-free), or via email at [email protected].
Quantity in commerce: 6790
Distribution: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Product codes and lots: 1811715 1831313 1831324 1831325

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1438-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1438-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code MRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)