FDA recall Z-1535-2020
Beckman Coulter, Inc. · Class II · device
Product
iChemVELOCITY Strips, Catalog 800-7212
Reason for recall
The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
Distribution
Distribution in US including Puerto Rico, Canada, and Taiwan
Key facts
- Status
- Terminated
- Initiation date
- 2020-02-17
- Report date
- 2020-04-01
- Termination date
- 2021-05-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Miami, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2020