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.
FDA Recall Z-1648-2014 · Posted 2014-05-21
Advertisement
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeKLI
Date Initiated2014-02-20
Date Terminated2017-04-19
Product Quantity583 units Total (357 units domestically & 226 units internationally)
Reason for Recall
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Firm 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 confirmation of receipt form and return by March 4, 2014. Forward a copy of the Product Correction Notice if the product was distributed outside of your facility. Fax to :
1.888.557.3759 or 1.585.453.4110
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement