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

Recall Z-1563-2013 — Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laborat

U.S. FDA — Device Enforcement · United States · 2013-05-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1563-2013
Date of alert: 2013-05-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Microgenics Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10014432

Reported risk: It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

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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