Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.
What this means for you
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 medical decisions, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2. The recall is due to the potential for false positive serum and plasma sample results.
The affected product is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG. The recall covers 19,368 units total, specifically 10,328 units from lot 212 and 9,040 units from lot 292.
The product was distributed worldwide, including nationwide in the United States and in various international markets. Users of the affected calibrator kits should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System f
- 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 (3)
- Product Code 1662659
- Lots: 1) 212 and 2) 292
- Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28.
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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