Health product recall

VITROS Chemistry Products CKMB Slides

Last updated

Summary

Product
VITROS Chemistry Products CKMB Slides
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalog number
VITROS Chemistry Products CKMB Slides All lots. 800 1133 805 8232

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive, Rochester, New York, United States, 14626

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-74578