Recall Z-1877-2016— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2016-04-05, terminated 2017-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.. Reason: Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-05
- Terminated
- 2017-11-30
- Firm location
- Buffalo Grove, IL, United States
Product description
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Reason for recall
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.