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Aptima®

Hologic, Inc. · Model CV/TV CONTROLS, APTIMA, 100T, IVD · UDI-DI 15420045512092

PQANSU Prescription
1
510(k) clearances
26
Adverse events
3
Recalls
7
Facilities

Description

Aptima® CV/TV Assay Controls Kit.

Recalls

DateFirmReason
2019-07-17Becton Dickinson & Co.The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2018-09-24Becton Dickinson & Co.A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vagin
2018-09-24Becton Dickinson & Co.A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vagin

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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.