Iq200 Series Analyzers And Dxu 840m/850m Iris Analyzers

Recalling firm
Beckman Coulter NZ Ltd
Product
iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. [Device]. Model: iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. Affected: All serial numbers
Reason
The manufacturer has received customer complaints about lamina fluid leaks in iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. Investigation determined that the leaks are caused by a check valve in the rinse line becoming structurally compromised. This may allow lamina fluid to migrate to internal instrument surfaces and eventually leak onto the table surface and/or floor.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-08-12
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/7da12851-c1df-475f-850a-17330031bde8