Recall Z-1710-2014— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2014-01-10, terminated 2017-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.. Reason: Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-10
- Terminated
- 2017-09-05
- Firm location
- Buffalo Grove, IL, United States
Product description
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
Reason for recall
Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.