Z-1002-2015Class II

Anti-Lambda APC-H7, Catalog Number 656157

Name: Z-1002-2015 Anti-Lambda APC-H7, Catalog Number 656157
Creator: BD Biosciences, Systems & Reagents
Published: 2014-12-19
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2014-12-19 / Terminated / root cause: supplier

FDA source

BD Biosciences, Systems & Reagents began a recall of Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders on 2014-12-19. FDA classified it as Class II and gives the reason as "Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1002-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-20
Terminated: 2016-03-11
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Root cause tag: supplier
FDA 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 in commerce: 15 units
Distribution: US Nationwide Distribution in the states of CA, NY, and MI
Product codes and lots: Lot numbers 4155632 with expiry date of 2015-06-30. Lot 42889687 was not shipped to customers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1002-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1002-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-20

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)