Device product
iChemVELOCITY Strips, Catalog 800-7212
Z-1535-2020
Product summary
- Event
- Event 85047
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10822 vials
- Official record key
device-enforcement:Z-1535-2020
Official wording
Reason: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Code information: Catalog 800-7212, UDI 10837461002628; Lot 7212269M
Distribution pattern: Distribution in US including Puerto Rico, Canada, and Taiwan
Derived failure modes
-
Unknown
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.