Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System (product code 6844458) due to potential erroneous test results from mispositioned MicroSlides in Slot 18 of the CM rotor. Affected units have serial numbers J34500122 to J34500231.
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.
Ortho Clinical Diagnostics is recalling its VITROS XT3400 Chemistry System because certain MicroSlides may become mispositioned in Slot 18 of the CM rotor, leading to inaccurate test results. This affects laboratory equipment used for medical testing, where precise results are critical for patient care.
The hazard occurs when MicroSlides in Slot 18 of the CM rotor become mispositioned during testing. This mispositioning can cause the system to produce inaccurate test results, which may lead to incorrect medical diagnoses if the equipment is used in a clinical setting.
Laboratories using the VITROS XT3400 Chemistry System with serial numbers J34500122 to J34500231 are most at risk. The affected units are specifically identified by their serial numbers and product code.
Check if your VITROS XT3400 Chemistry System has the product code 6844458 and serial numbers between J34500122 and J34500231. The system is used for laboratory testing and may be found in medical facilities.
Verify your VITROS XT3400 Chemistry System's serial numbers are between J34500122 and J34500231 to confirm if it is affected.
The recall is due to a potential mispositioning of MicroSlides in Slot 18 of the CM rotor, which can cause inaccurate test results.
Check your serial numbers to see if they fall within the range J34500122 to J34500231. If affected, contact Ortho Clinical Diagnostics for further instructions.
The recall record does not specify a fix or remedy; affected units may need to be replaced or corrected by the manufacturer.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2878-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2878-2020 from Ortho Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
