Z-1438-2020 Class II Terminated
FDA device recall Z-1438-2020 was initiated by Polymer Technology Systems, Inc. on January 21, 2020 and is designated Class II. Reason for recall: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. The recall status is terminated (terminated December 14, 2020). Affected quantity: 6790.
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- January 21, 2020
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6790
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Code Information
1811715 1831313 1831324 1831325