Ortho Vitros Myoglobin Calibrators Recalled for Stability Issues
Ortho Clinical Diagnostics is recalling Vitros Myoglobin Calibrators due to a stability issue that may cause calibration failures or atypical quality control results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential calibration failures or atypical quality control results, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling Vitros Myoglobin Calibrators, Product Code 6801043. These products are used for the calibration of VITROS ECi/ECiQ, VITROS 3600, and VITROS 5600 systems to measure myoglobin in human serum and plasma.
The recall is due to a stability issue in the calibrators that may cause calibration failures or atypical Quality Control results following a successful calibration. The affected units include Lots 1271 through 1310 (expired) and Lots 1315 and above (in-date).
A total of 4,030 units were distributed nationwide domestically and to various foreign countries including Australia, Brazil, Canada, and the UK. Users should contact Ortho Clinical Diagnostics for further instructions on handling the recalled product.
The recalled product
- Product
- Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 4,030
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 1271 through 1310 (expired) Lots 1315 & Above (in-date)
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ortho Clinical Diagnostics Inc
See all →- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · calibration failure
See all →- ModeratePhosphorus reagent lots recalled because calibration may fail before expiration date
FDA (Devices) · 2025-10-15
- ModerateBeckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
FDA (Devices) · 2025-05-21
- ModerateBeckman Coulter Access PCT Reagent Pack Recalled for Calibration Failures
FDA (Devices) · 2025-02-12
- ModerateDRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures
FDA (Devices) · 2025-01-22