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

Recall Z-0173-2020 — Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.

U.S. FDA — Device Enforcement · United States · 2019-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0173-2020
Date of alert
2019-05-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories
Product category
device
Product type
Devices
Reported risk: The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.
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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