Ortho-Clinical Diagnostics recalls refurbished VITROS ECi Immunodiagnostic System (Product Code 6801059) due to potential luminometer malfunction causing inability to process microwell assays on VITROS systems.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling refurbished VITROS ECi Immunodiagnostic Systems with Product Code 6801059. The recall is because these systems may have a luminometer malfunction that prevents proper processing of microwell assays. This could affect laboratory testing accuracy and patient results.
The luminometer in the system may malfunction, causing the device to be unable to process microwell assays. This could lead to inaccurate test results for clinical samples, potentially affecting patient care and diagnostic outcomes.
Laboratories using the refurbished VITROS ECi Immunodiagnostic System with Product Code 6801059 are affected. Those who have the system with serial numbers indicating a luminometer replacement during service repair are most at risk.
Check for the Product Code 6801059 on the refurbished VITROS ECi Immunodiagnostic System. Look for serial numbers that indicate the luminometer was replaced during a service repair. The Unique Device Identifier (UDI) 10758750001040 is associated with this recall.
Verify the product code on your VITROS ECi Immunodiagnostic System. The recalled product has Product Code 6801059.
Look for serial numbers that indicate the luminometer was replaced during a service repair. This is part of the recall criteria.
The refurbished VITROS ECi Immunodiagnostic System with Product Code 6801059.
The recall is due to potential luminometer malfunction that may cause the system to be unable to process microwell assays on VITROS systems.
Check for Product Code 6801059 and serial numbers indicating the luminometer was replaced during a service repair. The Unique Device Identifier (UDI) 10758750001040 is associated with this recall.
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-1293-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1293-2019 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.
