Ortho-Clinical recalls VITROS 5600 systems where microtip pack caps may not seal properly, causing delayed test results. Affected units have serial numbers J56000143-J56004477.
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 VITROS 5600 lab systems because the MicroTip Pack Opener Assembly might not properly remove or replace caps on the microtip packs. This could lead to delayed test results if a pack becomes unusable.
The MicroTip Pack Opener Assembly may not remove or replace the caps on the microtip packs correctly. This can cause the packs to become unusable, leading to delayed test results.
Lab users with VITROS 5600 systems that have serial numbers from J56000143 to J56004477. Healthcare facilities using these systems are most at risk.
Check your VITROS 5600 system's serial number, which should be in the range J56000143 to J56004477. The product code is 6802413 and UDI is 10758750002740.
Verify your VITROS 5600 system's serial number falls within the range J56000143 to J56004477.
The packs may become unusable, causing delayed test results.
Check the serial number, which should be in the range J56000143 to J56004477.
The recall does not specify a fix or remedy; you should check if your system is affected.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1556-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1556-2023 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.