Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supe

FDA device recall Z-1698-2014 · posted 2014-06-02 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

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.

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.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

NJT

Quantity affected

33 units

Distribution

Nationwide Distribution including AZ, CA, FL, and NY.

Date initiated

2014-02-26

Date posted

2014-06-02

Date terminated

2017-08-14

Location

Buffalo Grove, IL