Recall Z-1002-2015— BD Biosciences, Systems & Reagents
Class II · Terminated
Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2014-12-19, terminated 2016-03-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.. Reason: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody..
- Recalling firm
- BD Biosciences, Systems & Reagents
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2016-03-11
- Firm location
- San Jose, CA, United States
Product description
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Reason for recall
Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
Data sourced from openFDA. This site is unofficial and independent of the FDA.