Ortho-Clinical Diagnostics Recalls VITROS CKMB Slides Due to Incorrect Instructions
Ortho-Clinical Diagnostics is recalling VITROS CKMB Slides because Spanish and Swedish instructions incorrectly state the assay can be tested with plasma, which could result in biased results.
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, and the hazard involves a labeling error that could lead to biased results, fitting the criteria for moderate severity without reported injuries or hospitalizations.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CKMB Slides, Product Code 805 8232-300, UDI Number 10758750004294. The recall involves slides that expire after July 20, 2018, and are within their current expiry date. These products were distributed nationwide in the United States.
The recall was initiated because the Spanish and Swedish language versions of the Instructions for Use (IFU) incorrectly state that the assay can be tested with plasma. This statement is false and could result in biased test results. The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum, which was historically ordered to detect Myocardial Infarction.
No specific number of affected units or reported injuries is provided in the source text. Users of these products should verify the language of the instructions and consult the manufacturer for guidance on proper usage to ensure accurate testing.
The recalled product
- Product
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect…
- 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 (2)
- CKMB Slides that expire after July 20
- 2018 and within current expiry.
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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