Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 20 for potential biased lab results in transferrin, C3, C4, IgA, IgG and IgM tests. Affected units may show inaccurate results.
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
Ortho-Clinical Diagnostics is recalling its VITROS Chemistry Products Calibrator Kit 20 due to potential for biased lab results in certain blood tests. This could lead to inaccurate measurements of transferrin, C3, C4, IgA, IgG, and IgM. The recall affects specific lab equipment used in medical testing.
The calibrator kit may cause lab results to be biased, particularly for transferrin, C3, C4, IgA, IgG, and IgM. This means test results could be higher or lower than they should be, potentially leading to incorrect medical decisions. The bias is measured in percentages but does not cause immediate harm.
Lab technicians and healthcare providers using the VITROS 5,1 FS/4600 Chemistry Systems or VITROS 5600/XT 7600 Integrated Systems for blood tests. The risk is low as the issue only affects test accuracy, not patient safety directly.
Check for the product code 6801704 or lot code 2022 with expiration date 06-Sept-2023 on the calibrator kit. The kit is used with VITROS 5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for blood tests.
Look for product code 6801704 or lot code 2022 with expiration date 06-Sept-2023 on the calibrator kit.
This recall affects tests for transferrin, C3, C4, IgA, IgG, and IgM. The calibrator kit is used to calibrate blood tests in specific lab equipment.
The official recall does not mention a fix or remedy. Affected units should be checked and potentially replaced.
Check for product code 6801704 or lot code 2022 with expiration date 06-Sept-2023 on the calibrator kit.
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-2129-2023 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2129-2023 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.
