Recall Z-1648-2014 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Ortho-Clinical Diagnostics
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
| Date | May 21, 2014 (initiated Feb 20, 2014) |
| Status | Terminated |
| Reason | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. |
| Root cause | Other |
| Action | Ortho Clinical Diagnostics sent an Urgent Product Correction Notifications dated February 19, 2014, to all affected customers via Fed Ex and/or US Postal Service Priority Mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to immediately discontinue using and discard all remaining affected product. Customers should review their Quality Control results that were generated using the affected lot. Customers should consult their Laboratory Medical Director if they suspect that patient results were affected. Complete the |
| Quantity | 583 units Total (357 units domestically & 226 units internationally) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.