Device recall
Z-1438-2020: PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic…
FDA device recall · Class II · Polymer Technology Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1438-2020 |
|---|---|
| Recall event | 84840 |
| 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… |
| Product code | MRS |
| Recalling firm | Polymer Technology Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2020 |
| FEI number | 3015525148 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database