—#171457

Product

VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, 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: K182063
Affected lot / code info: Systems Running Software Version 3.4 & 3.4.1

Why it was recalled

One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.

Root cause (FDA determination)

Software design

Action the firm took

Urgent Product Correction Notification letters dated 3/11/19 were sent to customers.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA. The products were distributed to the following foreign countries: Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom

Timeline

Recall initiated: 2019-03-11
Terminated: 2020-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171457. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.