Polymer Technology Systems Recalls PTS Detect Cotinine In Vitro Diagnostic
Polymer Technology Systems is recalling PTS Detect Cotinine in vitro diagnostic devices due to a lack of FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is driven by a regulatory compliance issue (lack of 510(k) clearance) rather than a reported safety hazard, injury, or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Polymer Technology Systems, Inc. is recalling the PTS Detect Cotinine in vitro diagnostic, Reference No. 3061, UPC 381933061017. The product is used for the quantitative measurement of the nicotine metabolite cotinine in capillary or venous whole blood to determine if an individual has been exposed to nicotine.
The firm is removing the product from the market after discussions with the FDA due to a lack of 510(k) clearance. The recall involves 6,790 units.
The product was distributed domestically nationwide and internationally to Belgium, South Africa, South Korea, and Poland. Affected lots include codes 1811715, 1831313, 1831324, and 1831325.
The recalled product
- 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…
- Manufacturer
- Polymer Technology Systems, Inc.
- Affected units
- 6,790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1811715 1831313 1831324 1831325
Distribution
Distributed nationwide across the United States.
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