Aptima®

Hologic, Inc. · Model KIT, BOX 1, REFRIGERATED, ABV, 250T, IVD · UDI-DI 15420045517059

PQA PMN NSU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA®) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Recalls

Date	Firm	Reason
2019-07-17	Becton Dickinson & Co.	The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
2018-09-24	Becton 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
2018-09-24	Becton 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.