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Healgen Scientific Limited Liability Company · Model HCDOAEW-6125 · UDI-DI 00810173655118

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510(k) clearances

Adverse events

Recalls

Facilities

Description

K243365 12 Panel Cup Type #31: (AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MET1000/MOP300/MTD300/OXY100/PCP25/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.