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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products CREA Slides.

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  Class 3 Device Recall VITROS Chemistry Products CREA Slides. see related information
Date Initiated by Firm July 11, 2018
Create Date September 19, 2018
Recall Status1 Terminated 3 on August 19, 2020
Recall Number Z-3193-2018
Recall Event ID 80715
510(K)Number K063591  
Product Classification Enzymatic method, creatinine - Product Code JFY
Product VITROS Chemistry Products CREA Slides, Product Code 680 2584

Product Usage:
VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information GEN 7, GEN 10, GEN 12, GEN 13, GEN 15, GEN 16, GEN 18
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.
FDA Determined
Cause 2		 Process control
Action On 7/11/18, Important Product Correction Notification letters were distributed to customers. The letters instructed customers to perform the following actions: VITROS Cl- Slides and VITROS CREA Slides Instructions for Use will be updated to contain the revised information described in this letter; we will notify you upon availability. In the interim, retain a copy of this customer letter for your records. Calibration Diskette and ADD Data Release Version (DRV) 5992 (and above) will support the revised measuring range for VITROS CREA Slides. We anticipate that DRV 5992 will be available beginning on July 28, 2018 by eConnectivity or will be sent via your normal Cal Disk or ADD mailing. Prior to the availability of the revised IFU, be aware that if a serum or plasma sample contains a Triglyceride concentration of 600 mg/dL or higher, the Chloride result may be positively biased by approximately 2.1 mmol/L. Follow your normal laboratory procedures as you would for other known assay interferences. Note: It is acceptable to continue using VITROS Cl- Slides. Upon availability, install the Calibration Diskette or ADD to implement the revised Measuring Range: For VITROS 4600, 5600 or 5,1 FS Systems: Install ADD DRV 5992 or above, Select All Assay Data option For VITROS 250/350 Systems: Install Calibration Diskette DRV 5992 or above Refer to the enclosure for additional instructions to update the Measuring Range. Update laboratory procedures and your Laboratory Information System (LIS), as necessary. Retain this letter until we send a notification to alert you when the revised IFUs are available. Complete the Confirmation of Receipt form and return by July 25, 2018. Post this notification by each system that processes VITROS Cl- or CREA Slides. Forward this notification if the product was distributed outside of your facility.
Quantity in Commerce 627543
Distribution Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
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 = JFY and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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