Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides, Product Code 684 4471. These in vitro diagnostic products are used to quantitatively measure chloride concentration in serum, plasma, and urine using VITROS Chemistry Systems.
The recall was initiated because the slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Specifically, triglyceride interference was observed around a concentration of 600 mg/dL, whereas the product claims state that interference should not occur below 800 mg/dL.
The affected products were distributed worldwide, including in the United States and numerous international markets. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 420,105
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)
- GEN 10 and above
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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