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Aptima Combo 2®
Hologic, Inc. · Model KIT,APTIMA COMBO 2,250T,RT,CEIVD-UPDATED · UDI-DI 15420045512849
10
510(k) clearances
80
Adverse events
3
Recalls
22
Facilities
Description
Aptima Combo 2® Assay, 250 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.
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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Get your free API keyRead the docsData 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.