Z-1108-2013Class II

VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of...

Name: Z-1108-2013 VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of...
Creator: Ortho-Clinical Diagnostics
Published: 2013-02-07
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-02-07 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes on 2013-02-07. FDA classified it as Class II and gives the reason as "Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1108-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Posted: 2013-04-13
Terminated: 2017-04-20
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5600 Integrated System, Product Code 6802413. Intended for use in the measurement of a variety of chemistry analytes.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: URGENT MEDICAL DEVICE CORRECTION letters were sent to the consignees on 2/07/13. On/about 2/07/13, OCD trained service personnel started to perform an assessment of all the VITROS System(s) in End-User facilities worldwide to determine if the extension springs are out of manufacturing specifications. In addition, the slide alignment guides will also be inspected. If the extension springs are out of specification they will be replaced. Consignees will also be provided with a communication that explains the issue.
Quantity in commerce: USA: 775 units, Foreign: 800 units
Distribution: Worldwide Distribution- USA (nationwide) including Puerto Rico and countries of: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Republic of Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Serial Numbers 56000118 through 56001583

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1108-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1106-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-13
Z-1107-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-13
Z-1108-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)