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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Clinical Diagnostics

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  Class 2 Device Recall Ortho Clinical Diagnostics see related information
Date Initiated by Firm May 11, 2020
Create Date June 15, 2020
Recall Status1 Terminated 3 on September 22, 2021
Recall Number Z-2366-2020
Recall Event ID 85652
510(K)Number K812027  
Product Classification Starch-dye bound polymer, amylase - Product Code CIW
Product VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.

Code Information Current Control Assay Sheet SD 4.2, 4.3  Revised Control Assay Sheet SD 6.8, 7.1
Recalling Firm/
Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Mr. Joe Falvo
Manufacturer Reason
for Recall
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
FDA Determined
Cause 2
Under Investigation by firm
Action On May 11, 2020, Ortho Clinical Diagnostics, Inc. sent an Urgent Medical Device Correction Notification to their customers alerting them of important information regarding the precision of VITROS AMYL Slides. The notice stated that the imprecision affects serum, urine and QC samples, however VITROS AMYL Slides performance continues to meet its intended clinical use. The VITROS Performance Verifiers I and II Control Assay Sheet estimated within-lab SD, Range of Means (ROM) and Delta table values were re-evaluated. The Delta tables will be updated in a future revision of the Performance Verifier Training Module. In the meantime, customers were instructed to use the revised estimated within-lab SD listed in the enclosed Information sheet to evaluate their lab's quality control when using VITROS Performance Verifier I and II products. When available on the Ortho website, https://www.orthoclinicaldiagnostics.com, customers can obtain the updated VITROS Performance Verifier Control Assay Sheets and can use the revised ROM to evaluate the labs VITROS AMYL Slide quality control when using VITROS Performance Verifier I and II products. The firm explained that a review of previously reported patient results is NOT recommended. The customers were asked to Complete the Confirmation of Receipt form no later than May 19, 2020 and to forward the notification if the product was distributed outside of their facility.
Distribution Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska
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 = CIW and Original Applicant = EASTMAN KODAK COMPANY