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Rapid Response

BTNX Inc · Model D3.4-1P29-25 · UDI-DI 00722066000786

LDJDIODJCNFYNFWNGG Prescription
2
510(k) clearances
2
Adverse events
15
Recalls
102
Facilities

Description

Rapid Response Multi Drug Test Panels (MET/COC/THC) - 25 tests/ kit are for the qualitative determination of Methamphetamine, Cocaine and THC metabolites in urine.

Recalls

DateFirmReason
2023-10-04Family Dollar Stores, Llc.Products were stored outside of labeled temperature requirements.
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncXXX
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-02-10Carolina Liquid Chemistries CorpCorrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.