—#182637

Product

VITROS XT3400 Chemistry System, Product code 6844458

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: Serial numbers J34500122 J34500231

Why it was recalled

When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.

Root cause (FDA determination)

Process control

Action the firm took

The firm notified customers through Urgent Product Correction Notification letters on July 20, 2020. Customers were informed of the potential issue with incubator slot 18 of affected devices. Customers were provided with a table of the eight assays with biases which do not align with the assay's intended clinical use. Customers who had already been identified as experiencing this issue through their e-connected systems, or who did not have e-connected systems, received a letter stating that the recalling firm would be replacing the CM Rotor to resolve the issue. Customers who had e-connected systems but who had not yet been identified as experiencing this issue were informed that Ortho would continue to monitor their system for an increase in the frequency of condition codes related to slide misalignment. If impacted, those customers would also receive a replacement CM Rotor. Customer actions: " If you suspect an erroneous result has occurred or you observe an increase in the frequency of TH4-60J/TH4-63J condition codes, contact Ortho Care Technical Solutions Center. " Review the enclosed Assay Observed Bias sheet for VITROS Slides assays used by your laboratory. Discuss any concerns with your Laboratory Medical Director. " Complete the Confirmation of Receipt form and return to the firm " Post this notification by each VITROS XT 3400 and/or XT 7600 System in your facility or with the user documentation.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

Timeline

Recall initiated: 2020-07-20
Terminated: 2023-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182637. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.