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Recall Observatory FDA recall evidence

Device product

BD" Mouse IgG2a Isotype Control APC X39 ASR

Z-2333-2021

July 22, 2021

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 88341
Status
Terminated
Classification
Class II
Quantity
23 reagents
Official record key
device-enforcement:Z-2333-2021

Official wording

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 information: Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing process error