# K003721: Modification to Olympus AU2700 Clinical Chemistry Analyzer

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: Dec 18, 2000 after 14 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K161837: ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer (2016), 2 descendants of its own
- K220977: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (2023), 0 descendants of its own
- K183375: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (2019), 0 descendants of its own

## Recalls of this device
- 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
- Apr 26, 2013 · Class II · Z-1430-2013: Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated deter
- 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-0976-2012: The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

Source page: https://510kreport.com/device/K003721
Methodology: https://510kreport.com/methodology