Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1648-2014 — 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 thyr

U.S. FDA — Device Enforcement · United States · 2014-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1648-2014
Date of alert: 2014-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ortho-Clinical Diagnostics
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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