| Class 2 Device Recall VITROS Immunodiagnostic Products Free T3 Reagent Pack |  |
Date Initiated by Firm | April 09, 2024 |
Date Posted | May 14, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1818-2024 |
Recall Event ID |
94436 |
510(K)Number | K970016 K994145 |
Product Classification |
Radioimmunoassay, total triiodothyronine - Product Code CDP
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Product | VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin).
Product Code: 131 5589 |
Code Information |
UDI-DI: 10758750008797
Lot Numbers:
3042 Expiry: 09-Apr-2024;
3052 Expiry: 02-May-2024;
3061 Expiry: 06-Jun-2024;
3080 Expiry: 02-May-2024;
3090 Expiry: 14-Jun-2024;
3100 Expiry: 29-Jul-2024;
3110 Expiry: 13-Aug-2024;
3126 Expiry: 04-Sep-2024
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Recalling Firm/ Manufacturer |
QUIDELORTHO 100 Indigo Creek Dr Rochester NY 14626-5101
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Manufacturer Reason for Recall | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | QuidelOrtho issued Important Product Correction Notification issued April 9, 2024. Letter states reason for recall, health risk and action to take:
Discontinue using, render unusable, and discard affected lots of VITROS Free T3 Reagent Pack (and associated calibrators).
" Complete the enclosed Confirmation of Receipt form no later than April 17, 2024. Upon receipt of your completed form, QuidelOrtho will provide credit for, or replacement of, discarded product.
" Save this notification with your User Documentation or post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System until the issue has been resolved.
" Please forward this notification if the affected product was distributed outside of your facility.
" If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization.
Resolution
QuidelOrtho s investigation is on-going, and currently working to identify root cause.
Contact Global Services Organization at 1-800-421-3311. |
Quantity in Commerce | 21268 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, France, Germany,
India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore , Spain, Sweden, The Netherlands, United Kingdom.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = CDP 510(K)s with Product Code = CDP
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