Z-1535-2020 Class II Terminated
FDA device recall Z-1535-2020 was initiated by Beckman Coulter, Inc. on February 17, 2020 and is designated Class II. Reason for recall: The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. The recall status is terminated (terminated May 13, 2021). Affected quantity: 10822 vials.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 17, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10822 vials
Product Description
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 Pattern
Distribution in US including Puerto Rico, Canada, and Taiwan
Code Information
Catalog 800-7212, UDI 10837461002628; Lot 7212269M