Ortho-Clinical Diagnostics recalls VITROS ECi/ECiQ Immunodiagnostic Systems with serial numbers 30005946-30006005 due to potential luminometer malfunction causing inability to process microwell assays.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling VITROS ECi/ECiQ Immunodiagnostic Systems with specific serial numbers because a luminometer malfunction may prevent proper processing of microwell assays. This could lead to inaccurate test results if the system is used without the fix.
The luminometer in the VITROS ECi/ECiQ system may malfunction, causing the system to be unable to process microwell assays. This could result in inaccurate test results if the system is used without the fix.
Healthcare facilities using the VITROS ECi/ECiQ systems with serial numbers 30005946 through 30006005 are most at risk. These systems are used for in vitro diagnostic testing in clinical settings.
Check the serial numbers on your VITROS ECi/ECiQ system: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979, 30005981 through 30005991, 30005993, 30005994, and 30006000 through 30006005.
Verify your VITROS ECi/ECiQ system's serial number against the list: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979, 30005981 through 30005991, 30005993, 30005994, 30006000 through 30006005.
Product code 1922814.
Serial numbers 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979, 30005981 through 30005991, 30005993, 30005994, and 30006000 through 30006005.
The luminometer may malfunction, causing the system to be unable to process microwell assays.
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-1292-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1292-2019 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.
