VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or hepari

FDA device recall Z-1648-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

Action taken

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

Status

Terminated

Product code

KLI

Quantity affected

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 S

Date initiated

2014-02-20

Date posted

2014-05-21

Date terminated

2017-04-19

Location

Rochester, NY