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DOA

RANDOX LABORATORIES LIMITED · Model EV3500 · UDI-DI 05055273202137

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of drugs in human urine. They are competitive enzyme immunoassays.

Recalls

Date	Firm	Reason
2005-05-31	Applied Biotech Inc	The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in

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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.