CLASS II Device recall · Reported 13 Feb 2019 · FDA Enforcement Report

Architect Total T3 Reagent Kit used on Architect i1000SR recalled

Abbott Ireland Diagnostics Division is recalling Architect Total T3 Reagent Kit used on Architect i1000SR or i2000/i2000SR platforms, distributed nationwide in the US. The recall was initiated on 12 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesList number (Kit Configuration): 7K64 20 (4 x 100 test/kit), 7K64 25 (1 x 100 tests/kit), 7K64 30 (4 x 500 tests/kit), 7K64 35 (1 x 500 tests/kit), 7K64 27 (1 x 100 tests/kit), 7K64 32 (4 x 500 tests/kit), 7K64 37 (1 x 500 tests/kit). All lot codes for each of these list numbers are included in the recall.

Quantity recalled191,410 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0799-2019
FDA event ID: 81402
Recalling firm: Abbott Ireland Diagnostics Division, Co. Longford
Classification: Class II
Status: Terminated
Recall initiated: 12 Oct 2018
FDA classified: 4 Feb 2019
Reported: 13 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

12 Oct 2018	Recall initiated by company
4 Feb 2019	Classified by FDA	+115 days
13 Feb 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

ARCHITECT Total 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.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

List number (Kit Configuration): 7K64 20 (4 x 100 test/kit), 7K64 25 (1 x 100 tests/kit), 7K64 30 (4 x 500 tests/kit), 7K64 35 (1 x 500 tests/kit), 7K64 27 (1 x 100 tests/kit), 7K64 32 (4 x 500 tests/kit), 7K64 37 (1 x 500 tests/kit). All lot codes for each of these list numbers are included in the recall.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 81402

This product is part of a recall event; the main page for the event is Architect Free T3 Reagent Kit used on Architect i1000SR recalled.

Reported	Class	Recall	Company	Reason	Where
13 Feb 2019	CLASS II	Architect Free T3 Reagent Kit used on Architect i1000SR recalled	Abbott Ireland Diagnostics Division	Potency & Assay	Nationwide

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