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

Recall Z-0179-2015 — Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4)

U.S. FDA — Device Enforcement · United States · 2014-04-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0179-2015
Date of alert: 2014-04-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Microsystems, Inc.
Product category: device
Product type: Devices

Reported risk: Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link 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.

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