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Class 3 Device Recall VITROS Immunodiagnostic Products TT4 Reagent Pack |
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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
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Product Classification |
Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
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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
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For Additional Information Contact |
Joe Falvo 585-453-3000
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Manufacturer Reason for Recall |
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
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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
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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.
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510(K) Database |
510(K)s with Product Code = KLI and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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