Z-1648-2014Class II

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

Name: Z-1648-2014 VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma...
Creator: Ortho-Clinical Diagnostics
Published: 2014-02-20
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-02-20 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ... on 2014-02-20. FDA classified it as Class II and gives the reason as "Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1648-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-20
Posted: 2014-05-21
Terminated: 2017-04-19
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Root cause tag: manufacturing process
FDA 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 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
Quantity in commerce: 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.
Product codes and lots: Catalog Number: 139 3396, Lot Number: 1590

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1648-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1648-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

Product code KLI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)