Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho Clinical Diagnostics is recalling 89 units of the VITROS 5600 Integrated System, a clinical chemistry analyzer, due to a software anomaly. The issue affects software version 3.3.2 or above and may result in unsuccessful calibrations. The affected units were distributed worldwide, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses, injuries, or deaths associated with this defect. The primary risk is related to the potential for the device to fail calibration, which could impact the accuracy of clinical chemistry testing.
Healthcare facilities and users of the VITROS 5600 Integrated System should contact Ortho Clinical Diagnostics for further instructions on how to address the software anomaly and ensure proper device operation.
The recalled product
- Product
- VITROS 5600 Integrated System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 89
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 System Recalled for Software Calibration Error
FDA (Devices) · 2015-01-21
- 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
- SevereOrtho-Clinical VITROS 5600 Chemistry System Software Recall
FDA (Devices) · 2016-01-20
- LowOrtho-Clinical VITROS Software Recall Due to Calibration Failure
FDA (Devices) · 2015-01-28
- HighOrtho VITROS 4600 Chemistry System Recalled for Software Error
FDA (Devices) · 2014-08-13