VITROS Chemistry Products CKMB Slides

Per the VITROS CKMB slides instructions for use (IFU) "principles of the procedure" section, the spread layer of the CKMB slide contains goat antihuman CK-mm antibodies, which inhibit CK-mm (muscle) activity and ~50% of the CK-mb (heart) activity. The remaining CK activity represents 50% of the total CK-mb isoenzyme activity plus any CK-bb (which is relatively rare). Per the current VITROS CKMB slides IFU "known interferences" section, a total CK activity greater than 1000 u/l may result in falsely elevated CK-mb results. It is limited at 1000 u/l by design, which is due to the level of goat antihuman CK-mm antibodies added during manufacturing. Samples with total CK >1000 u/l should be diluted prior to analysis. Therefore, CK will not typically impact VITROS CKMB results below the CK result of 1000 u/l. Ortho Clinical Diagnostics (Quidelortho) has confirmed the issue and determined that lots manufactured from coating 0261 of VITROS CKMB slides do not adequately inhibit CK-mm up to a total CK >1000 u/l (as stated in the IFU).

Recall Start Date: October 30, 2023