Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
This recall has been terminated (originally issued June 2, 2014).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- February 26, 2014
- Posted
- June 2, 2014
- Terminated
- August 14, 2017
- Recall Number
- Z-1698-2014
- Quantity
- 33 units
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
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
Nationwide Distribution including AZ, CA, FL, and NY.
Lot / Code Info
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
Root Cause
Incorrect or no expiration date
Action Taken
Leica Biosystems sent a Medical Device Recall Notification letter dated February 26, 2014 to all direct accounts. The letter advised that clinicians may want to review results obtained from the affected products. The letter also included instructions for customers to: 1) appropriately destroy any unused or partially used NCL-L-GSTpi-438 (lots 6018777, 6023260,6026297, 6026980) reagent or confirm that they are not in stock; 2) complete and return the attached Medical Device Recall Notification Acknowledgement Form to 847-236-3747; and, 3) contact the local Leica representative immediately if replacement is required. Customers with questions or concerns about this recall can contact Leica via e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.