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Aptima Combo 2®
Hologic, Inc. · Model KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATED · UDI-DI 15420045512832
10
510(k) clearances
41
Adverse events
4
Recalls
23
Facilities
Description
Aptima Combo 2® Assay, 250 test, box 1 of 2 (2°C to 8°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 |
|---|---|---|
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-09-12 | Abbott Molecular, Inc. | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit |
| 2023-03-29 | Binx Health, Inc. | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative C |
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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.