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

Recall Z-0387-2018 — Phadia 1000 Instrument, Article Number 12-3800-01.

U.S. FDA — Device Enforcement · United States · 2017-07-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0387-2018
Date of alert
2017-07-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Phadia US Inc
Product category
device
Product type
Devices
Reported risk: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test 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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