Z-1698-2014 Class II Terminated
FDA device recall Z-1698-2014 was initiated by Leica Microsystems, Inc. on Feb 26, 2014 and is designated Class II. 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… The recall status is terminated (terminated Aug 14, 2017). Affected quantity: 33 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 11, 2014
- Initiation Date
- Feb 26, 2014
- Termination Date
- Aug 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
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.
Distribution Pattern
Nationwide Distribution including AZ, CA, FL, and NY.
Code Information
Product Code: NCL-L-GSTpi-438; Lot Numbers and Expiration Dates: 6018777, Expires 2014-05; 6023260, Expires 2014-12; 6026297, Expires 2015-05; 6026980, Expires 2015-06
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1698-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026