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.
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, and the hazard involves a labeling error that could lead to biased results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CKMB Slides, Product Code 8001133-90, UDI Number 10758750004201. 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 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.
Healthcare facilities and laboratories should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - 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 Myocardial
- 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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