Ortho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability
Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.
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 potential for instability without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 2,573 units of Urine Electrolyte Diluent (Product Code 1112352). The product is used to dilute urine specimens for the analysis of sodium and potassium on specific VITROS Chemistry and Integrated Systems.
The recall was initiated due to a potential for instability in the diluent when stored in a 2mL cup for 7 days. The source text also references VITROS 7% BSA (Product Code 8262487) in the context of this instability issue.
The affected lots are V6391 (expiry 2020-02-26), W6895 (expiry 2020-09-20), X7127 (expiry 2021-01-17), and Y7593 (expiry 2021-08-28). The products were distributed worldwide, including the United States and various international markets. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Hazard
- Affected units
- 2,573
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho Clinical Diagnostics Inc 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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