Z-0913-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- October 28, 2019
- Termination Date
- April 1, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4314 devices
Product Description
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.
Reason for Recall
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).
Distribution Pattern
Worldwide distributions.
Code Information
UDI: 10837461009375, 10837461001751; All Part Numbers