FDAJanuary 21, 2020device
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 deter...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
What to do
FDA enforcement status: Terminated
Brands named
polymer technology systemspolymerpolymer technology
UPCs
381933061017
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCJunpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries; Sold on Amazon by JSNJ_Tech Store2026-07-02
- CPSCCombination Smoke and Carbon Monoxide (CO) Detectors Recalled Due to Risk of Serious Injury or Death from Failure to Alert Consumers to Fire; Sold Exclusively on Amazon.com by Treatlife Technology2026-06-25
- CPSCLuminous Fidget Spinner Balls Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by Anzmtosn2026-05-28
- FDAPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Elev...2026-05-18
- FDAPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # ...2026-05-18
- CPSCSuperbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop2026-05-14
- CPSCGenerac Power Systems Expands Recall of Generac and DR Power Electric Start Pressure Washers Due to Risk of Serious Injury or Death from Carbon Monoxide Hazard; Includes Additional Models2026-05-14
- CPSCTiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Sold on Amazon by ZW Creations2026-05-14
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