Aptima®

Hologic, Inc. · Model KIT, BX 1 (REF) ACT, 100T, AS, IVD · UDI-DI 15420045505407

MKZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Aptima® CT assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Chlamydia trachomatis assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.

Recalls

Date	Firm	Reason
2010-09-29	Becton Dickinson & Co.	In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results.
2009-09-18	Becton Dickinson & Co.	Product was shipped beyond its expiration date.
2004-07-07	Roche Molecular Systems Inc	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.

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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.