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RTCII 2nd gen.

AMERICAN BIO MEDICA CORPORATION · Model 10-14BOX3KE-030 · UDI-DI 10694644500377

LDJLCMJXMDJGDISDIODKZLAFLFGDJR Prescription
1
510(k) clearances
2
Adverse events
15
Recalls
101
Facilities

Description

14 Drug MINICUP THC/COC150/METH500/OPI300/AMP500/PCP/BZO/BAR/BUP/OXY/MTD/MDMA500/K2/ETG

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 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.
2020-08-18Ameditech 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.