Ortho VITROS Sodium Slides Recalled for False Positive Results
Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.
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. The hazard involves false positive results which could lead to incorrect clinical decisions, but the source does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2. The recall is due to the potential for false positive serum and plasma sample results.
The affected products are used to quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using specific VITROS Chemistry Systems. The recall covers 548,663 units with Product Code 8379034, Generations 7 through 13, and expiry dates from November 1, 2013, to January 1, 2015.
Distribution was worldwide, including the United States (nationwide, Puerto Rico, and specific states) and numerous international countries. Healthcare facilities and laboratories should stop using the affected lots and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 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…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 548,663
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)
- Product Code 8379034
- Affected Generations (GENs)/Lots: GENs 7 - 13
- Expiry Dates: 2013-11-01 thru 2015-01-01
Distribution
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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