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Medline

MEDLINE INDUSTRIES, INC. · Model DYND30215 · UDI-DI 10080196032006

OIE
0
510(k) clearances
10
Adverse events
1
Recalls
47
Facilities

Description

KIT,MIDSTREAM,FUNNEL,BZK,4OZ CUP

Recalls

DateFirmReason
2014-04-17Gen-Probe IncIncorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collect

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.