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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products GLU Slides

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  Class 2 Device Recall VITROS Chemistry Products GLU Slides see related information
Date Initiated by Firm August 11, 2016
Create Date October 17, 2016
Recall Status1 Terminated 3 on June 11, 2018
Recall Number Z-0089-2017
Recall Event ID 74950
510(K)Number K955286  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD ---
For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
Code Information Current/In-date GENs 10, 11, 20 through 31
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in Commerce US: 192,459 sales units; Foreign: 231,710 sales units
Distribution Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
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.
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