Medical device recalls Moderate risk

Becton, Dickinson and Company, BD Biosciences recalls BD" Mouse IgG2a Isotype Control APC X39 ASR

Recall date
July 22, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2333-2021
FDA classification
Class II
Brand / firm
Becton, Dickinson and Company, BD Biosciences
Sold / distributed
Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD" Mouse IgG2a Isotype Control APC X39 ASR

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