# K981743: Olympus AU400 Clinical Chemistry Analyzer

- Pathway: 510(k) (Special)
- Applicant: Olympus America, Inc.
- Decided: Jun 9, 1998 after 22 days
- Product code: CKB (Acid Phosphatase, Naphthyl Phosphate)
- Device class: 2
- Regulation: 21 CFR 862.1020
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own
- K130915: XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent Pack (2014), 0 descendants of its own

## Recalls of this device
- Aug 3, 2026 · Class II · Z-3332-2026: Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software,
- Apr 30, 2025 · Class II · Z-1907-2025: A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for 
- 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.

## Indications for use
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.

Source page: https://510kreport.com/device/K981743
Methodology: https://510kreport.com/methodology