Class 2 Device Recall OrthoClinical Diagnostics

• Date Initiated by Firm: April 01, 2020
• Create Date: May 08, 2020
• Recall Status: Terminated on January 19, 2021
• Recall Number: Z-1931-2020
• Recall Event ID: 85363
• 510(K)Number: K861387
• Product Classification: Differential rate kinetic method, cpk or isoenzymes - Product Code JHS
• 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.
• Code Information: CKMB Slides that expire after July 20, 2018 and within current expiry.
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 513 Technology Blvd; Rochester NY 14626-3601
• For Additional Information Contact: Mr. Joe Falvo; 585-453-3452
• Manufacturer Reason for Recall: 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 Determined Cause: Labeling design
• Action: An Urgent Product Correction letter was sent on April 1, 2020 to affected customers stating that the Spanish and Swedish IFU versions for the VITROS CK-MB slides incorrectly included plasma as a sample type in the Intended Use section. Customers were instructed to complete and return the Confirmation of Receipt form then, determine whether the effected IFUs were being used in their laboratory and identify any plasma samples that were taken while using those instructions for use. The laboratory directors should determine how to handle the assays that used plasma samples. The firm directed customers to go to the Ortho-Clinical Diagnostics website to download the updated Spanish and Swedish IFUs.
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JHS