Recall Z-1438-2020 ยท MRS Test System, Nicotine, Cotinine, Metabolites
Polymer Technology Systems, Inc.
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.
| Date | Feb 20, 2020 (initiated Jan 21, 2020) |
| Status | Terminated |
| Reason | The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. |
| 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 |
| Quantity | 6790 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.