Data Foundry

Medical device recalls 2014

Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase… — Class II medical device recall Z-1698-2014

Terminated recall by Leica Microsystems, Inc., reported 2014-06-11, distributed nationwide. Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does

Recall numberZ-1698-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLeica Microsystems, Inc., Buffalo Grove, IL, United States
Recall initiated2014-02-26
Classified2014-06-02
Reported by FDA2014-06-11
Terminated2017-08-14
DistributedNationwide (US)
Quantity33 units
Reason classeslabeling, specification failure
Lot numbers2014-05, 2014-12, 2015-05, 2015-06, 6018777, 6023260, 6026297, 6026980

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1698-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.