Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.
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 by definition is unlikely to cause adverse health consequences. The issue is a technical performance deviation regarding interference claims rather than a direct safety hazard like contamination or device failure causing injury.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides, Product Code 844 5207. These products are used for in vitro diagnostic testing to quantitatively measure chloride concentration in serum and plasma using specific 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 at a concentration of 600 mg/dL, whereas the product claims state that interference should not occur below 800 mg/dL.
The affected units were distributed worldwide, including the United States and various international markets. The source text does not specify the number of affected units, specific lot numbers, or dates of distribution. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- Product
- VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 128,196
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 5 and below
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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