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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products TT4 Reagent Pack

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  Class 3 Device Recall VITROS Immunodiagnostic Products TT4 Reagent Pack see related information
Date Initiated by Firm March 10, 2020
Create Date April 30, 2020
Recall Status1 Terminated 3 on September 26, 2022
Recall Number Z-1834-2020
Recall Event ID 85298
510(K)Number K160495  
Product Classification Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
Product VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Code Information UDI: 10758750005147; Lot Number: 2340
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Joe Falvo
585-453-3000
Manufacturer Reason
for Recall		 The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
FDA Determined
Cause 2		 Under Investigation by firm
Action IMPORTANT PRODUCT CORRECTION NOTIFICATION letters dated 3/10/20 were sent to customers. REQUIRED ACTIONS " If you have VITROS TT4 Reagent Packs Lot 2340 in your inventory, Ortho will replace or credit your account as indicated on your Confirmation of Receipt form. NOTE: As a reminder, if you have a successful calibration, and quality control results are acceptable, it is acceptable to continue using the affected lot. " Post this notification by each system that processes VITROS TT4 Reagent Packs, Lot 2340. " Complete the Confirmation of Receipt form now to register receipt of the notification. All customers should return the completed form by March 25, 2020. " If you are satisfied with the product at this time but want Lot 2340 replaced in the future, you may resubmit the Confirmation of Receipt form at that time, indicating the quantity that requires replacement. " In the event of future occurrences, retain a copy of the Confirmation of Receipt form and re-submit if needed. " Please forward this notification if the product was distributed outside of your facility. Contact Information We apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 3181
Distribution US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.
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 = KLI and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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