Ortho-Clinical Diagnostics recalls refurbished VITROS 5600 Integrated Systems that may dispense insufficient sample volume, leading to incorrect test results. Affected units have specific serial numbers.
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 refurbished VITROS 5600 Integrated Systems that could dispense too little sample volume, causing inaccurate test results. This affects laboratory equipment used for medical testing.
The system may dispense an insufficient sample volume onto a MicroSlide, which can lead to incorrect test results. This happens due to a potential issue with the sample dispensing mechanism in refurbished units.
Laboratories using refurbished VITROS 5600 Integrated Systems are affected. Medical testing accuracy is the primary concern, but no injuries have been reported.
Check for the VITROS 5600 Integrated System with specific serial numbers listed in the recall notice. Refurbished units are identified by the catalog number 6802915.
Compare your unit's serial number with the list of affected serial numbers provided in the recall notice.
The VITROS 5600 Integrated System may dispense insufficient sample volume, leading to incorrect test results in refurbished units.
Check if your unit has a serial number listed in the provided recall notice (US and OUS serial numbers).
No action is required if your unit's serial number is not on the list of affected units.
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-0080-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0080-2019 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.
