Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System with serial numbers J76000050-J76000566 due to potential erroneous test results from mispositioned MicroSlides in Slot 18 of the CM rotor.
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 VITROS XT7600 Integrated Systems with specific serial numbers because certain MicroSlides may become mispositioned during testing, leading to inaccurate test results. This could affect laboratory test accuracy if the system is used without correction.
When processing MicroSlides in Slot 18 of the CM rotor, the slides may become mispositioned. This mispositioning can cause the system to produce inaccurate test results, potentially leading to incorrect medical diagnoses.
Laboratories using the VITROS XT7600 Integrated System with serial numbers J76000050 to J76000566 are most at risk. The affected units are typically used in clinical settings for blood testing.
Check if your VITROS XT7600 Integrated System has a serial number between J76000050 and J76000566. The product code is 6844461.
Verify your system's serial number falls within the range J76000050 to J76000566.
The recall occurs because MicroSlides in Slot 18 of the CM rotor may become mispositioned, leading to inaccurate test results.
Check your serial number against the range J76000050 to J76000566. If affected, contact Ortho Clinical Diagnostics for further instructions.
The recall record does not specify a remedy or fix, so no corrective action is mentioned.
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-2879-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2879-2020 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.
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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.
