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Aptima®
Hologic, Inc. · Model APTIMA GC ASSAY FLUIDS · UDI-DI 15420045506282
LSL
Prescription
10
510(k) clearances
196
Adverse events
7
Recalls
28
Facilities
Description
Aptima® GC assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Neisseria gonorrhoeae assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Tigris® DTS® System or semi-automated instrumentation as specified.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-09 | Cepheid | Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its i |
| 2015-07-27 | Cepheid | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date. |
| 2015-07-27 | Cepheid | Firm determined that some lots of CT/NG Swab 50 and CT/NG Urine collection kits contain a sub component with an expiry date that is earlier than the kit expiration date. |
| 2005-01-10 | Becton Dickinson & Co. | An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections. |
| 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. |
| 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. |
| 2003-07-21 | Becton Dickinson & Co. | Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results. |
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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.