Recalls / —
—#125895
Product
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 product code
- KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Catalog Number: 139 3396, Lot Number: 1590
Why it was recalled
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Root cause (FDA determination)
Other
Action the firm took
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
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 100 Indigo Creek Dr, Rochester, New York 14626-5101
Distribution
- 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.
Timeline
- Recall initiated
- 2014-02-20
- Posted by FDA
- 2014-05-21
- Terminated
- 2017-04-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.