FDAFDA · Food and drugs·Recall number 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.
Published February 13, 2019 · Recall initiated: October 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Ireland Diagnostics Division
- Distributor
- Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR. International distribution to AFGHANISTAN, ALBANIA, ALGERIA, ANGOLA, ARMENIA, AUSTRIA, AZERBAIJAN, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVI, BRUNEI, BULGARIA, BURKINA FASO, CAMEROON, CANADA, CAYMAN ISLANDS, CHILE, CROATIA, CYPRUS, CZECH REPUBLIC, DEM. REP. OF THE CON, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GHANA, GREECE, HONDURAS, HUNGARY, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAWI, MALAYSIA, MALDIVES, MALI, MAURITANIA, MAURITIUS, MOLDOVA, MONTENEGRO, MOROCCO, MOZAMBIQUE, NEPAL, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, RWANDA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA,SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, ST. LUCIA, ST. VINCENT, SWEDEN, SWITZERLAND, TANZANIA, THE GAMBIA,TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UGANDA, UKRAINE,UNITED KINGDOM, VIETNAM, ZIMBABWE.
- Lot
- List number (Kit Configuration): 7K63-20 (4 x 100 tests/kit), 7K63 25 (1 x 100 tests/kit), 7K63 27 (1 x 100 tests/kit), 7K63 30 (4 x 500 tests/kit), 7K63 35 (1 x 500 tests/kit), 7K63 32 (4 x 500 tests/kit), 7K63 37 (1 x 500 tests/kit). All lot codes for each of these list numbers are included in the recall.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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