VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (
FDA device recall Z-1818-2024 · posted 2024-05-14 · Open, Classified
Recall details
- Recalling firm
- QUIDELORTHO
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- CDP
- Quantity affected
- 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,
- Date initiated
- 2024-04-09
- Date posted
- 2024-05-14
- Location
- Rochester, NY
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS (K994145) | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 |
| VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) (K970016) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-01-30 |