Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the source text does not report any injuries, illnesses, or deaths, indicating a moderate risk of harm.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32, which is used with the VITROS clinical chemistry analyzer. The recall is being conducted because a software anomaly in the VITROS system may result in unsuccessful calibration.
The affected product is identified by product code 6844508 and UDI 10758750032105. The recall covers worldwide distribution, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines.
Users of the VITROS system should contact Ortho Clinical Diagnostics for further instructions regarding the software anomaly and calibration issues.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
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)
- product code: 6844508 UDI: 10758750032105
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Ortho Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · software anomaly
See all →- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo infusion pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10
Similar recalls
- ModerateOrtho VITROS 5600 Integrated System Recalled for Calibration Anomaly
FDA (Devices) · 2014-10-22
- ModerateOrtho VITROS 4600 Chemistry System Recalled for Software Calibration Error
FDA (Devices) · 2015-01-21
- ModerateOrtho VITROS 5600 System Recalled for Software Calibration Error
FDA (Devices) · 2015-01-21
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly
FDA (Devices) · 2014-10-22
- LowOrtho-Clinical VITROS Software Recall Due to Calibration Failure
FDA (Devices) · 2015-01-28
- ModerateOrtho-Clinical VITROS 350 Chemistry System Software Recall
FDA (Devices) · 2016-03-16