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

Recall Z-0798-2019 — ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

U.S. FDA — Device Enforcement · Ireland · 2018-10-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0798-2019
Date of alert: 2018-10-12
Country / jurisdiction: Ireland
Risk level: Class II
Risk type: recall
Brand: Abbott Ireland Diagnostics Division
Product category: device
Product type: Devices

Reported risk: Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms.

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

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Recall Z-0798-2019 — ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

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