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

Recall Z-0086-2021 — DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001

U.S. FDA — Device Enforcement · United States · 2020-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0086-2021
Date of alert
2020-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05987750001
Reported risk: Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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.