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.
Reported: March 11, 2020 Initiated: January 21, 2020 #Z-1438-2020
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.
Details
- Recalling Firm
- Polymer Technology Systems, Inc.
- Units Affected
- 6790
- Distribution
- Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Polymer Technology Systems, Inc.. Units affected: 6790.
Why was this product recalled? ▼
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1438-2020.
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