FDA Medical Device Recalls (openFDA)
BD Biosciences, Systems & Reagents: CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
- Recall number
- Z-1375-2015
- Recalling firm
- BD Biosciences, Systems & Reagents
- Product
- CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
- Status
- Terminated
- Initiated
- 2015-03-23
- Posted
- 2015-04-02
- Terminated
- 2016-02-26
- 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.
- Root cause
- Under Investigation by 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.
- Quantity
- 9
- Distribution
- US Distribution in states of: MO, GA, AZ, NE, TX, VA
- Lot, serial or model codes
- Lot 5008762, Exp 11/30/16.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MVU
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28