Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.
What this means for you
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 involves a medical device with a potential for biased diagnostic results, which poses a risk of harm to patients through incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445, for in vitro diagnostic use. The recall affects units with Software Version 3.0 and lower and serial numbers J46000108 through J46000403. The total quantity involved is 82 domestic units and 213 foreign units.
The recall is issued because of a potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System, and the VITROS 5,1 Chemistry System. MW codes may be associated with results from VITROS Chemistry Products using multiple point (multipoint) rate measurements.
The affected products were distributed worldwide, including the United States, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users of these systems should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (2)
- Software Version 3.0 and lower
- Serial Numbers J46000108 through J46000403
Distribution
Part of a larger recall action
This product is one of 3 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 3 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
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · biased results
See all →- HighLDL cholesterol assays recalled over triglyceride interference causing biased results
FDA (Devices) · 2026-01-28
- LowOrtho VITROS Chemistry Performance Verifier II Recalled for Product Instability
FDA (Devices) · 2020-11-25
- ModerateOrtho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions
FDA (Devices) · 2020-05-20
- SevereOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides
FDA (Devices) · 2019-03-20
- ModerateOrtho VITROS VANC Reagent Recalled for Potential Biased Test Results
FDA (Devices) · 2017-05-03