Recall Z-1348-2016— Ortho-Clinical Diagnostics

Name: FDA recall Z-1348-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-16

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2016-02-16, terminated 2018-05-30. It names one FDA 510(k) clearance: K081543. Product: 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.. Reason: 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..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Terminated: 2018-05-30
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K081543 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc.·cleared 2008-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.