Ortho Clinical Diagnostics recalls refurbished VITROS 3600 systems with serial numbers starting 36000192-36001042 due to potential parameter reset affecting test accuracy.
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Ortho Clinical Diagnostics is recalling refurbished VITROS 3600 Immunodiagnostic Systems with specific serial numbers. These units may reset to default settings during use, which could lead to inaccurate test results if not properly configured.
The system may inadvertently reset to default settings during certain operations, which could cause the microwell qualitative assay parameters to be lost. This might result in inaccurate test results if the system is not properly reconfigured after the reset.
Lab users who own or operate the recalled refurbished VITROS 3600 systems with serial numbers starting from 36000192 to 36001042 are affected. Laboratory technicians and medical staff using these systems for diagnostic testing are most at risk of inaccurate results.
Check your VITROS 3600 system's serial number. The affected units have serial numbers starting with 36000192 through 36001042. This recall applies only to refurbished products with the specific product code 6802914.
Verify your VITROS 3600 system's serial number to see if it starts with 36000192 through 36001042.
The recall is for refurbished VITROS 3600 Immunodiagnostic Systems that may reset to default settings, potentially causing inaccurate test results if not properly reconfigured.
Check your serial number to see if it starts with 36000192 through 36001042. If affected, contact Ortho Clinical Diagnostics for further instructions.
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-2481-2020 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2481-2020 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.
