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Healgen Scientific Limited Liability Company · Model HCDOAV-2145 · UDI-DI 00810173655088

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510(k) clearances

Adverse events

Recalls

Facilities

Description

K243365 14 Panel Cup Type #22 with Clicker: AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOR300, MTD300, OXY100, PCP25, TCA1000, THC50

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.