Recall Z-1438-2020— Polymer Technology Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2020-01-21, terminated 2020-12-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance..
- Recalling firm
- Polymer Technology Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-21
- Terminated
- 2020-12-14
- Firm location
- Indianapolis, IN, United States
Product description
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.
Reason for recall
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.