Recall Z-1698-2014— Leica Microsystems, Inc.
Class II · Terminated
Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2014-02-26, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.. Reason: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity..
- Recalling firm
- Leica Microsystems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-26
- Terminated
- 2017-08-14
- Firm location
- Buffalo Grove, IL, United States
Product description
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
Reason for recall
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.