Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1698-2014 — Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

U.S. FDA — Device Enforcement · United States · 2014-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1698-2014
Date of alert: 2014-02-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Microsystems, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1698-2014 — Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.

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