Dxc 500i Clinical Analyzer

Recalling firm
Beckman Coulter NZ Ltd
Product
DxC 500i Clinical Analyzer. [Device]. Model: DxC 500 AU Module w/ISE, DxC 500i and DxC 500 AU Module, DxC 500i. Affected: Reference: C63522, C63521 - Software: 1.5 or lower
Reason
The manufacturer has determined that a modification made by operators to the below 25 predefined calculated rules, which are included as part of the parameter package, will revert to the default expression following parameter package or software upgrades.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-07-16
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/248a9d3c-3657-4afd-a1c5-0872470a3953