Device product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Z-2333-2021
Product summary
- 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
manufacturing process error