Z-1698-2014Class II

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

Name: Z-1698-2014 Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue...
Creator: Leica Microsystems, Inc.
Published: 2014-02-26
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2014-02-26 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use on 2014-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1698-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-26
Posted: 2014-06-02
Terminated: 2017-08-14
Recalling firm: Leica Microsystems, Inc.
Product: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: labeling and UDI
FDA 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 replacement is required. Customers with questions or concerns about this recall can contact Leica via e-mail at [email protected]. For questions regarding this recall call 847-405-5413.
Quantity in commerce: 33 units
Distribution: Nationwide Distribution including AZ, CA, FL, and NY.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1698-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1698-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)