Modification to Olympus AU2700 Clinical Chemistry Analyzer

510(k) K003721

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK003721	Date18 Dec 2000Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0152-2014 FDA Class II initiated 9 Sep 2013
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 can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected.
- Terminated Z-1430-2013 FDA Class II initiated 26 Apr 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 detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time, causing a leak.
2 recalls, same reason
- Terminated Z-0974-2012 FDA Unclassified (pre-2012) initiated 12 Jul 2010
- Terminated Z-0976-2012 FDA Unclassified (pre-2012) initiated 12 Jul 2010
The recall was initiated because Beckman has confirmed that the AU Clinical Chemistry Analyzers may experience cuvette overflow.

1 jurisdiction

United States — FDA 510(k) Active

510(k)