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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 June 17, 2019
Create Date August 06, 2019
Recall Status1 Terminated 3 on November 09, 2020
Recall Number Z-2202-2019
Recall Event ID 83228
510(K)Number K182072  K955286  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product VITROS Chemistry Products GLU Slides-Product Code:1707801.

IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Code Information Lot Number:0048-0964-9287; Exp Date:2020-11-01 UDI: 10758750009572
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact SAME
585-453-4224
Manufacturer Reason
for Recall		 Potentially Biased Results using VITROS Chemistry Products GLU Slides
FDA Determined
Cause 2		 Process control
Action Ortho issued On 17 June 2019, a customer letter (Ref. CL2019-172) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to customers and distributors. The customers were notified of the issue and instructed: Discontinue using Lot 0048-0964-9287, discard any remaining inventory and switch to an alternate lot. " If you do NOT have an alternate lot, consider the following alternate options: o Use an alternate glucose method until your replacement order arrives. o Consult with your medical director to determine if the bias observed and rate of occurrence when using the affected lot is acceptable for continued use, and if so, continue to use until your replacement arrives. " Ortho will credit and/or replace your remaining inventory of Lot 0048-0964-9287. Please specify full and/or partial sales units remaining and indicate your preference of credit or replacement on your Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than June 21, 2019. " Post this notification by each system that processes VITROS GLU Slides or with your user documentation until you switch to an alternate lot. " Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 1099 (5 pack x 60)=329700 slides
Distribution US Nationwide Distribution - AL, AR, CA, CO, CT, FL, KS, KY, MA, MN, TN
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 = CGA and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
510(K)s with Product Code = CGA and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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