FDA recall Z-1438-2020

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 for recall

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Distribution

Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.

Key facts

Status

Terminated

Initiation date

2020-01-21

Report date

2020-03-11

Termination date

2020-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2020