Z-1914-2016Class II

VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and...

Name: Z-1914-2016 VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and...
Creator: Ortho-Clinical Diagnostics
Published: 2016-04-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-04-06 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog... on 2016-04-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1914-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Posted: 2016-06-06
Terminated: 2018-06-01
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
Distribution: 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.
Product codes and lots: Software Version 3.2.2 & below; VITROS 5600 Serial Numbers J56000024 - J56002387; VITROS 5600 (Refurbished) US Serial Numbers: 56000186, 56000308, 56000315, 56000327, 56000339, 56000458, 56000559, 56000718, 56000727, 56000741, 56000747, 56000750, 56000786, 56000792, 56000824, 56001062, 56001235, 56001635, 56001641; Foreign Serial Numbers: 56000147, 56000200, 56000214, 56000245,56000283, 56000330, 56000331, 56000362, 56000377, 56000399, 56000413, 56000416, 56000428, 56000437, 56000438, 56000439, 56000459, 56000463, 56000464, 56000466, 56000515, 56000528, 56000537, 56000555, 56000560, 56000632, 56000642, 56000669, 56000680, 56000749, 56000867, 56001133, 56001135, 56001246, 56001461, 56001482, 56001487, 56001859. Unique Device Identifier No. 10758750002740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1914-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1913-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1914-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06

Product code JJE

K081543Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 5600 Integrated SystemOrtho-Clinical Diagnostics, Inc. / cleared 2008-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)