Device product

CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

Z-1375-2015

March 23, 2015

Class II

Product summary

Firm: BD Biosciences, Systems & Reagents
Event: Event 70811
Status: Terminated
Classification: Class II
Quantity: 9
Official record key: device-enforcement:Z-1375-2015

Official wording

Reason: One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.

Code information: Lot 5008762, Exp 11/30/16.

Distribution pattern: US Distribution in states of: MO, GA, AZ, NE, TX, VA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.