Ortho-Clinical Diagnostics recalls VITROS Anti-HBc IgM Controls (Lot 1690) due to possible delayed test results from incorrect troubleshooting. No safety risk but may affect lab results.
Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBc IgM Controls (Product Code 6801427) because some lot 1690 units have incorrect troubleshooting instructions. This could cause delayed test results but does not affect patient test accuracy.
The controls booklet for Lot 1690 contains information for the wrong product. This may lead to delayed test results when lab staff troubleshoot Quality Control issues, but patient test results remain accurate.
Lab technicians and healthcare facilities using the VITROS 5600/XT 7600 or VITROS ECi/ECiQ/3600 systems with Lot 1690 controls. Those most at risk are labs that rely on these controls for routine testing.
Check for Product Code 6801427 with Lot Number 1690 on the control vial or booklet. These controls are used with VITROS ECi/ECiQ/3600 or VITROS 5600/XT 7600 Integrated Systems.
Look for Lot 1690 on the control vial or booklet to identify affected units.
No, the recall does not involve safety risks. Patient test results remain accurate, but there is a potential for delayed results due to troubleshooting.
Check for Product Code 6801427 with Lot Number 1690 on the control vial or booklet.
No, patient test results are not affected. The issue only causes potential delays in troubleshooting Quality Control results.
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-0247-2022 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0247-2022 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.
