FDA Enforcement
Class II
Terminated
BD" Mouse IgG2a Isotype Control APC X39 ASR
Recall: Z-2333-2021
·
Reported September 1, 2021
Enforcement
- Recall Number
- Z-2333-2021
- Event ID
- 88341
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton, Dickinson and Company, BD Biosciences
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 1, 2021
- Initiation Date
- July 22, 2021
- Classification Date
- August 24, 2021
- Termination Date
- March 24, 2023
- Address
- 2350 Qume Dr, N/A, San Jose, CA, 95131-1812, United States
Description
BD" Mouse IgG2a Isotype Control APC X39 ASR
Reason
Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
Code Info
Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
Quantity
23 reagents