Ortho Clinical Diagnostics recalls Vitros Myoglobin Calibrators (Product Code 6801043) due to potential calibration failures or atypical quality control results after successful calibration. Affected lots 1271-1310 (expired) and 1315+ (in-date) for VITROS ECi/ECiQ, 3600, and 5600 systems.
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Ortho Clinical Diagnostics recalls Vitros Myoglobin Calibrators (Product Code 6801043) that may cause calibration failures or atypical quality control results after successful calibration. This affects laboratory equipment used in myoglobin testing for blood samples.
The calibrators may become unstable after calibration, leading to inaccurate test results. This could cause false positive or negative myoglobin measurements in blood tests, potentially affecting patient diagnosis and treatment decisions.
Laboratories using Vitros Myoglobin Calibrators with Product Code 6801043 for myoglobin testing in blood samples. Lab technicians and clinical staff handling these calibrators are most at risk.
Check the product code on the calibrator label for 6801043. Verify the lot number: affected lots are 1271 through 1310 (expired) or 1315 and above (in-date) for VITROS ECi/ECiQ, 3600, and 5600 systems.
Look for Product Code 6801043 on the calibrator label.
Confirm the lot number is 1271-1310 (expired) or 1315+ (in-date) for affected systems.
The product code is 6801043.
The calibrators are used with VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System, and VITROS 5600 Integrated System.
Unstable calibrators may cause calibration failures or atypical quality control results after successful calibration.
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-0844-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-0844-2019 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.
