Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1375-2015 · Posted 2015-04-02

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeMVU
Date Initiated2015-03-23
Date Terminated2016-02-26
Product Quantity9

Reason for Recall

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.

Firm Action

Recall letters were sent to affected sites on March 23, 2015 by certified mail. All product in house was placed on ship hold and remaining inventory is in process of being scrapped.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑