Recall Z-1818-2024 ยท CDP Radioimmunoassay, Total Triiodothyronine
QUIDELORTHO
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
| Date | May 14, 2024 (initiated Apr 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970016 | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) Johnson & Johnson Clinical Diagnostics, Inc., Jan 30, 1997 |
| K994145 | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS Ortho-Clinical Diagnostics, Inc., Dec 22, 1999 |