# K934593: Bact/Alert 120

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Feb 9, 1994 after 138 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 19, 2006 · Not classified · Z-0644-2007: Bottle data is not sent to BacT/ALERT 3D instrument.
- Aug 14, 2006 · Not classified · Z-0774-2007: Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

Source page: https://510kreport.com/device/K934593
Methodology: https://510kreport.com/methodology