Recall Z-1698-2014 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
| Date | Jun 2, 2014 (initiated Feb 26, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Incorrect or no expiration date |
| Action | 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 re |
| Quantity | 33 units |
| Distribution | Nationwide Distribution including AZ, CA, FL, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.