Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.
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, but the source text explicitly states that results are acceptable if Quality Control is within limits, indicating a low-risk, theoretical hazard without reported injuries.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides (UPN 10758750004812) used for in vitro diagnostic testing of sodium concentration. The recall involves 659,957 units distributed worldwide, including in the United States and 19 other countries.
The recall is due to a potential for biased results when the slide cartridges are warmed at room temperature, loaded onto the analyzer after meeting minimum warm-up requirements, and then stored on the analyzer for the full 10-day limit. The source text notes that if Quality Control (QC) results are within acceptable limits, the reported results are considered acceptable and were not affected by this issue.
Healthcare facilities and laboratories should check their inventory for the affected generation numbers (1 through 6, 30 through 40, 44 through 49) and expiry dates (January 1, 2017, through June 1, 2018). Users should review their Quality Control records to determine if their results were impacted.
The recalled product
- Product
- VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
- 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 (3)
- Generation (GEN): 1 through 6
- 30 through 40
- 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
Distribution
Distributed nationwide across the United States.
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