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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - P
Recalled May 20, 2020 · FDA recall Z-1931-2020 · Ortho-Clinical Diagnostics
Hazard
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results. · FDA Class II
Units
N/A
Sold at
US Nationwide distribution.
Description
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
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 Infarction.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →