FDA-Device2021-09-01Class II

BD" Mouse IgG2a Isotype Control APC X39 ASR

Becton, Dickinson and Company, BD Biosciences
Hazard

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.

Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
Affected count
23 reagents
Manufactured in
2350 Qume Dr, N/A, San Jose, CA, United States
Products
BD" Mouse IgG2a Isotype Control APC X39 ASR

Official notice

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

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