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Terminated

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.

FDA Recall Z-1914-2016 · Posted None

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2016-04-06
Date Terminated2018-06-01
Product QuantityVITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units

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.

Firm Action

On 4/6/2016,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2016-076, dated 4/06/2016) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. Install Software Version 3.2.3 at their earliest convenience. Foreign affiliates were informed of the issue by e-mail on 4/6/2016, and instructed to notify their consignees of the issue and required actions.

Root Cause

Software design

Distribution Pattern

Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEMOrtho-Clinical Diagnostics, Inc. · 2008-10-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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