Home / Recalls / Abbott Ireland Diagnostics Division / Z-0798-2019

Z-0798-2019 Class II Terminated

Recalled by Abbott Ireland Diagnostics Division — Co. Longford

Recall Details

Product Type
Devices
Report Date
February 13, 2019
Initiation Date
October 12, 2018
Termination Date
December 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
191,410 units total

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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.

Other recalls by Abbott Ireland Diagnostics Division

  • Z-1353-2019 Class II — Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol (February 5, 2019)
  • Z-1354-2019 Class II — Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assa (February 5, 2019)
  • Z-0668-2019 Class II — Alinity i Progesterone Reagent Kit, List Number 08P3620 (November 21, 2018)
  • Z-0666-2019 Class II — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 (November 21, 2018)
  • Z-0669-2019 Class II — Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 (November 21, 2018)
  • Z-0667-2019 Class II — Alinity i Estradiol Reagent Kit, List Number 07P5020 (November 21, 2018)
  • Z-0665-2019 Class II — Alinity i Free T4 Reagent Kit, List Number 07P7030 (November 21, 2018)
  • Z-2208-2019 Class II — Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin a (November 21, 2018)
  • Z-0664-2019 Class II — Alinity i TSH Reagent Kit, List Number 07P4830 (November 21, 2018)
  • Z-0799-2019 Class II — ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platfo (October 12, 2018)