Aptima®

Hologic, Inc. · Model KIT, BOX 1, REFRIGERATED, ABV, 100T, IVD · UDI-DI 15420045512023

PMN PQA NSU Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Aptima® BV assay, 100 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
2019-05-16	Microbiologics Inc	Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-04-09	Microbiologics Inc	Product with incorrect shelf life.
2019-01-31	Microbiologics Inc	Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 months.

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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.