Ortho-Clinical Diagnostics Recalls VITROS Urine Assay Data Disks
Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.
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 describes a software anomaly affecting sample processing without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving potential diagnostic errors or low-risk contamination without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling Assay Data Disks (ADD) for VITROS Urine Assays, specifically Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos). The recall involves 2,387 units distributed worldwide, including the United States, Brazil, Chile, Mexico, Australia, and several European and Asian countries.
The recall is due to a software anomaly that may allow urine samples requiring acidified pretreatment to be metered from the same sample container as assays that require no pretreatment. This error could occur when the sample is programmed, potentially affecting the accuracy of the diagnostic results.
Healthcare facilities and laboratories using these specific VITROS Urine Assays should stop using the affected Assay Data Disks and contact Ortho-Clinical Diagnostics for further instructions. The affected product code is 6801876, and the Unique Device Identifier is 10758750001576.
The recalled product
- Product
- Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires…
- 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: 6801876 Unique Device Identifier Numbers: 10758750001576
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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