Device product
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Z-0032-2026
Product summary
- Event
- Event 97390
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 116
- Official record key
device-enforcement:Z-0032-2026
Official wording
Reason: On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Code information: REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Distribution pattern: Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea
Derived failure modes
-
Unknown
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.