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Identify Health

MEDICAL DISTRIBUTION GROUP INC · Model ID-H14-ADULT-1-AZ25 · UDI-DI 10850013035189

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10
510(k) clearances
3
Adverse events
15
Recalls
102
Facilities

Description

Identify Health, 14 Panel Drug Screen Test Cup, CLIA Waived (AMP500, BAR300, BUP10, BZO300, COC150, EDDP300, MDMA500, MET500, MTD300, OPI300, OXY100, PCP25, TCA1000, THC50) + (SG, pH, OX) + (CR,Nl,GL) Contents: Test Cups - 25, Package Insert - 1, Adulteration Card - 1, Security Seals - 25, For In Vitro Diagnostics Use

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.