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Aptima Combo 2®

Hologic, Inc. · Model KIT,APT. COMBO 2 (ROOM TEMP)CE · UDI-DI 15420045505353

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal 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.