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Vitros chemistry products ckmb slides
Official notice
10 Nov 2023
Last checked
10 Nov 2023
An official Health Canada notice concerns 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 Published 2023-11-10.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74578
Official notice
2023-11-10
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Ortho-clinical Diagnostics, Vitros Chemistry Ckmb Slides.
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Documents, notices & source
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