Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-1648-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 20, 2014

Date Posted: May 28, 2014

Recall Number: Z-1648-2014

Event ID: 67643

Reason for Recall:

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

Status: Terminated

Product Quantity: 583 units Total (357 units domestically & 226 units internationally)

Code Information:

Catalog Number: 139 3396, Lot Number: 1590

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.

Voluntary or Mandated:

Voluntary: Firm initiated