Device product
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
Z-0913-2020
Product summary
- Event
- Event 84577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4314 devices
- Official record key
device-enforcement:Z-0913-2020
Official wording
Reason: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
Code information: UDI: 10837461009375, 10837461001751; All Part Numbers
Distribution pattern: Worldwide distributions.
Derived failure modes
-
Unknown
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).