Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21195
Brand Name: Dimension clinical chemistry Ammonia Flex® Reagent Cartridge
Model:
Affected: Dimension AMM
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
Millennium Centre, Part Level 2, Building A
600 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare Diagnostics Inc
Issue: In September 2014, the manufacturer issued Customer Notification DC 14-09 that addressed a high rate of Abnormal assay test report messages for its Dimension Ammonia (AMM) assay. The manufacturer is now reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM IFU revision E will reflect this change.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/3/2017
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