# K961274: Olympus AU600 Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jul 5, 1996 after 94 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K072140: S40 Clinical Analyzer, S Test Bil, S Test Bun, S Test Glu (2008), 1 descendant of its own
- K063804: Olympus Triglyceride Test System (2007), 1 descendant of its own
- K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (2024), 0 descendants of its own
- K120369: Hitachi Clinical Analyzer S Test Reagent Cartridge Glucose (Glu) (2012), 0 descendants of its own
- K083040: S-Test C-Reactive Protein (CRP) (2009), 0 descendants of its own

## Recalls of this device
- Apr 30, 2025 · Class II · Z-1908-2025: Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to t
- Feb 13, 2017 · Class II · Z-1704-2017: Beckman Coulter is recalling the Rack ID Labels because the Rack ID number displayed and the Rack ID barcode label do not match.
- Jul 30, 2015 · Class II · Z-2309-2016: Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting i
- Sep 9, 2013 · Class II · Z-0153-2014: The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure ca
- Sep 9, 2013 · Class II · Z-0152-2014: The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure ca
- Jul 12, 2010 · Not classified · Z-0974-2012: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.
- Jul 12, 2010 · Not classified · Z-0975-2012: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

Source page: https://510kreport.com/device/K961274
Methodology: https://510kreport.com/methodology