PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system

FDA device recall Z-1438-2020 · posted 2020-02-20 · Terminated

Recall details

Recalling firm

Polymer Technology Systems, Inc.

Reason for recall

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Action taken

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 response@ptsdiagnostics.com.

Root cause

No Marketing Application

Status

Terminated

Product code

MRS

Quantity affected

6790

Distribution

Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.

Date initiated

2020-01-21

Date posted

2020-02-20

Date terminated

2020-12-14

Location

Indianapolis, IN