—#118321

Product

VITROS 5600 Integrated System (product code 6802413) 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.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K081543
Affected lot / code info: Serial numbers: J56000110, J56000118 and J56001095 through J56001507

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2013-05-06
Posted by FDA: 2013-07-02
Terminated: 2018-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118321. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.