Recalls / —

—#108022

Product

VITROS® 5,1 FS System, Product Codes: 6801375 & 6801890 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

K063144

Affected lot / code info

Serial number range: 34002115 - 34002243

Why it was recalled

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Ortho Clinical Diagnostics (OCD) sent an Important Product Correction Notification letter dated March 15, 2012 via FedEx overnight courier to all affected customers. Foreign affiliates were informed by email on 15 March 2012 of the issue and instructed to notify their consignees of the issue and actions. The letter identified the affected products, problem and actions to be taken. The letter instructed customers to: 1) Consider performing the backup procedure more frequently to help prevent the loss of data on your system; 2) Contact OCD Customer Technical Service representatives if a hard drive failure occurs on your system; A Field Engineer will be dispatched to replace the hard drive on your system; 3) Complete and return the Confirmation of Receipt form upon receipt of this notification; and 4) Post this notification by each VITROS System in your facility or with the user documentation. For questions, refer to the Questions and Answers section. For additional questions, contact Customer Technical Services at 1-800-421-3311.

Recalling firm

Firm

Ortho-Clinical Diagnostics

Address

1000 Lee Road, Rochester, New York 14606

Distribution

Distribution pattern

Worldwide Distribution

Timeline

Recall initiated

2012-03-15

Posted by FDA

2012-04-26

Terminated

2017-09-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #108022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.