PTS Detect Cotinine recall
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative…
Why was PTS Detect Cotinine recalled?
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1811715 1831313 1831324 1831325
- Product
- PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative…
- Recalling firm
- Polymer Technology Systems, Inc.
- Quantity
- 6790
- Distribution
- Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
- Recall date
- March 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)