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

Recall Z-1348-2016 — VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

U.S. FDA — Device Enforcement · United States · 2016-02-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1348-2016
Date of alert
2016-02-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750002740
Reported risk: The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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