FDA recall Z-2333-2021

Becton, Dickinson and Company, BD Biosciences · Class II · device

Product

BD" Mouse IgG2a Isotype Control APC X39 ASR

Reason for recall

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.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.

Key facts

Status: Terminated
Initiation date: 2021-07-22
Report date: 2021-09-01
Termination date: 2023-03-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2021