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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Black Reference Slides

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  Class 2 Device Recall VITROS Black Reference Slides see related information
Date Initiated by Firm March 26, 2021
Create Date April 23, 2021
Recall Status1 Terminated 3 on May 24, 2023
Recall Number Z-1489-2021
Recall Event ID 87649
510(K)Number K182063  
Product Classification unknown device name - Product Code N/A
Product VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Code Information Lots: 9252-0058-3361, 9252-0058-3362
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, INc.
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Joe Falvo
585-453-3452
Manufacturer Reason
for Recall		 Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 3/25/2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice via letter notifying customers two lots of the VITROS Black Reference Slides have the incorrect part number on the box.
Quantity in Commerce 865 units of 25 slides each
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
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 = N/A and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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