Recall Z-1914-2016— Ortho-Clinical Diagnostics

Name: FDA recall Z-1914-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-06

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2016-04-06, terminated 2018-06-01. It names one FDA 510(k) clearance: K081543. Product: VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.. Reason: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Terminated: 2018-06-01
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, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.

Reason for recall

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

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