Z-2481-2021 Class II Terminated
FDA device recall Z-2481-2021 was initiated by Leica Microsystems, Inc. on July 30, 2021 and is designated Class II. Reason for recall: Product may not perform as specified in IFU. The recall status is terminated (terminated June 22, 2023). Affected quantity: 237 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 30, 2021
- Termination Date
- June 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237 units
Product Description
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Reason for Recall
Product may not perform as specified in IFU.
Distribution Pattern
US Nationwide distribution.
Code Information
Product Code PA0375, Lot 69909