Ortho Vitros Myoglobin Calibrators Recall: Calibration Failures Risk
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.
Lower-risk recall
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69416-ortho-vitros-myoglobin-calibrators-recall-calibration-failures-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69416-ortho-vitros-myoglobin-calibrators-recall-calibration-failures-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0844-2019
Cite this page
“Ortho Vitros Myoglobin Calibrators Recall: Calibration Failures Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69416-ortho-vitros-myoglobin-calibrators-recall-calibration-failures-risk. Based on FDA recall #Z-0844-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Ortho Clinical Diagnostics- Category
Medical device
What to do — step by step
Check Product Code
Look for Product Code 6801043 on the calibrator label.
Verify Lot Number
Confirm the lot number is 1271-1310 (expired) or 1315+ (in-date) for affected systems.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distributed nationwide domestically. Foreign distribution to Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0844-2019 (November 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0844-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.