Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall OrthoClinical Diagnostics

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall OrthoClinical Diagnostics see related information
Date Initiated by Firm April 01, 2020
Create Date May 08, 2020
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = EASTMAN KODAK COMPANY
-
-