Home › Hologic, Inc. › Aptima®
Aptima®
Hologic, Inc. · Model KIT, ASSAY FLUIDS, APTIMA, AS · UDI-DI 15420045500280
10
510(k) clearances
80
Adverse events
3
Recalls
22
Facilities
Description
The Aptima® Assay Fluids Kit is for use on the Panther® System.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.