Z-0641-2016Class II

VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916...

Name: Z-0641-2016 VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916...
Creator: Ortho-Clinical Diagnostics
Published: 2015-11-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2015-11-03 / Terminated / root cause: software

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and... on 2015-11-03. FDA classified it as Class II and gives the reason as "Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the...". 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-0641-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-03
Posted: 2016-01-13
Terminated: 2018-05-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.
Root cause tag: software
FDA root cause: Software design
Action: Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-211, dated November 3, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications 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 devices (VITROS 3600 and 5600 Systems). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/03/2015 of the issue and instructed to notify their consignees of the issue and required actions. Ortho-Clinical Diagnostics sent an Urgent Product Correction Letters (Ref. CL2015-221, dated November 11, 2015) via FedEx overnight courier and/ or ORTHO PLUS e-Communications 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 devices (VITROS 5,1 FS and 4600 users). The notification identified the affected products, problem and actions to be taken. Foreign affiliates were informed via e-mail on 11/11/2015 of the issue and instructed to notify their consignees of the issue and required actions.
Quantity in commerce: Domestic: 1083, Foreign: 999
Distribution: Worldwide Distribution - US Nationwide and the countries of Puerto Rico, and foreign distribution to: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Israel, Italy, Japan, Kenya, Mexico, Panama, Philippines, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, and Venezuela.
Product codes and lots: Software Version 3.2 and below; Serial Numbers J56000024 - J56002309

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0641-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0640-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13
Z-0641-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13
Z-0642-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13
Z-0643-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-13

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