FDA Medical Device Recalls (openFDA)
BD Biosciences, Systems & Reagents: Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
- Recall number
- Z-1002-2015
- Recalling firm
- BD Biosciences, Systems & Reagents
- Product
- Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
- Status
- Terminated
- Initiated
- 2014-12-19
- Posted
- 2015-01-20
- Terminated
- 2016-03-11
- Reason
- Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
- Root cause
- Vendor change control
- Action
- BD sent a Recall notification letters dated December, 2014 to affected customers via Certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for affected lots, immediately remove affected reagents from their laboratory, request replacement product and complete and return the enclosed Tracking/Verification form, per the instructions. For questions contact BD Customer Support at 855-236-2772.
- Quantity
- 15 units
- Distribution
- US Nationwide Distribution in the states of CA, NY, and MI
- Lot, serial or model codes
- Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.
- 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