Ortho-Clinical recalls refurbished VITROS 5600 systems where microtip pack caps may not seal properly, leading to delayed test results. Affected units have specific serial numbers.
MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable
Ortho-Clinical is recalling refurbished VITROS 5600 laboratory systems because the MicroTip Pack Opener Assembly might not properly remove or replace microtip pack caps. This could cause test results to be delayed if a pack becomes unusable.
The MicroTip Pack Opener Assembly may not properly remove or replace the microtip pack caps. This can cause the packs to become unusable, leading to delayed test results if the system requires the packs to be functional.
Lab users with refurbished VITROS 5600 systems that have serial numbers from J56000147 to J56003653 are affected. Clinical labs using these systems for blood tests are most at risk.
Check your VITROS 5600 system's serial number, which should be between J56000147 and J56003653. This applies to refurbished units sold with the product code 6802915.
Verify your VITROS 5600 system's serial number is within the range J56000147 to J56003653.
The MicroTip Pack Opener Assembly may not properly remove or replace microtip pack caps, which can cause test results to be delayed if a pack becomes unusable.
Check your serial number to see if it falls within the range J56000147 to J56003653. If affected, contact Ortho-Clinical 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 to request your refund or repair — edit it as you like.
Subject: Recall Z-1557-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1557-2023 from Ortho-Clinical. 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.
