Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated Systems that may dispense insufficient sample volume, causing incorrect test results. Affected units have catalog number 6802413 and serial numbers J56000024 to J56003300.
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems that might give incorrect test results due to improper sample dispensing. This could lead to inaccurate medical testing if the device is used without the fix.
The device may dispense too little sample onto the MicroSlide, which can cause the test to show incorrect results. This could lead to wrong medical diagnoses or treatment decisions if the system is used without correction.
Healthcare facilities using the VITROS 5600 Integrated System for clinical testing are most likely affected. Patients receiving tests from these systems may be at risk of inaccurate results.
Check for catalog number 6802413 and serial numbers starting with J56000024 through J56003300. The VITROS 5600 Integrated System is used for clinical testing in laboratories.
Identify if your VITROS 5600 Integrated System has catalog number 6802413 and serial numbers J56000024 to J56003300.
The VITROS 5600 Integrated System may dispense insufficient sample volume, which can cause incorrect test results.
Check if your device has the catalog number 6802413 and serial numbers J56000024 through J56003300. If it does, contact Ortho-Clinical Diagnostics for guidance.
The recall record does not specify a remedy or fix for this issue.
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-0079-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0079-2019 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.
