Z-1650-2013Class II

VITROS 3600 Immunodiagnostic System (product code 6802783)

Name: Z-1650-2013 VITROS 3600 Immunodiagnostic System (product code 6802783)
Creator: Ortho-Clinical Diagnostics
Published: 2013-05-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-05-06 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement... on 2013-05-06. FDA classified it as Class II and gives the reason as "There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1650-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-07-02
Terminated: 2018-05-16
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Root cause tag: design
FDA root cause: Device Design
Action: Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letters dated May 6, 2013 and response forms to all affected customers. Ortho Clinical Diagnostics informed their customers of the issue and advised if they detect the smell of melting plastic or observe smoke originating from your VITROS System, to immediately power down the system and contact OCD for assistance. They were also advised to consider performing the backup procedure more frequently to help prevent the loss of data on their Systems. In the near future, an OCD Field Engineer will contact customers who are affected and perform a Modification (MOD) procedure that will replace their potentially affected Wire Connector(s). Foreign affiliates were informed by email on May 6, 2013 of the issue and instructed to notify their customers of the issue and actions. OCD also found that this wire connector is commonly used in many types of computers (i.e., medical devices, personal computers, etc.). On 29 May 2013, OCD expanded their recall to incllude ORTHO Assay Software (OAS) Servers. As a precaution, OCD sent notifications to encompass all ORTHO Assay Software (OAS) Servers that potentially contain this type of wire connector. The letters (Ref. CL13-154) were sent via US Priority Mail to all customers who were shipped an affected OAS Server. Ortho Clinical Diagnostics has requested that customers with any questions or in need of additional information, please call Customer Technical Services at 1-800-421-3311.
Quantity in commerce: Total 98 units (30 units domestically & 68 units internationally)
Distribution: Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain
Product codes and lots: Serial numbers: J36000111 and J36000520 through J36000617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1647-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1648-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1649-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1650-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01
Z-1651-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code JJE

K083173Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics / cleared 2008-12-22

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)