Z-0798-2019Class II

ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms

Name: Z-0798-2019 ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms
Creator: Abbott Ireland Diagnostics Division
Published: 2018-10-12
License: https://open.fda.gov/license/

Abbott Ireland Diagnostics Division / initiated 2018-10-12 / Terminated / root cause: design

FDA source

Abbott Ireland Diagnostics Division began a recall of ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for... on 2018-10-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0798-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-12
Posted: 2019-02-04
Terminated: 2020-12-14
Recalling firm: Abbott Ireland Diagnostics Division
Product: 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.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
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.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott notified customers on about 10/12/218 via "Product Correction Urgent - Immediate Action Required" letter. Letters were sent separately to customers who utilize the ARCHITECH i1000SR platform and the i2000/i2000SR platforms. Necessary actions for customers who utilize the ARCHITECH i1000SR platform included that if a separate instrument can be used, then separate the ARCHITECT Free T3 and ARCHITECT Total T3 assays from the specific assays listed in the letter (ARCHITECT TSH, ARCHITECT TUptake, ARCHITECT HIV Ag/Ab Combo, ARCHITECT Cortisol, ARCHITECT LH, ARCHITECT ProGRP, ARCHITECT rHTLVI/II, ARCHITECT Total PSA, ARCHITECT AFP, ARCHITECT Free PSA, ARCHITECT 25OH Vitamin D), by running these tests on different instruments. For those customers who cannot use a separate instrument, then they are instructed to perform the Maintenance Procedure (6445 Pipettor/WZ Probe Cleaning for i1000SR) in the i1000SR Operations on the instrument prior to performing batch testing for all ARCHITECT Free T3 or ARCHITECT Total T3 samples. Necessary actions for customers who utilize the i2000/i2000SR platforms included that if a separate instrument can be used, then separate the ARCHITECT Free T3 and ARCHITECT Total T3 assays from the ARCHITECT 25OH Vitamin D assay, by running these tests on different instruments. For those customers who cannot use a separate instrument, then perform Daily Maintenance (Operations Manual, 6041 for i2000/i2000SR) on the instrument prior to performing batch testing for all ARCHITECT Free T3 or ARCHITECT Total T3 samples. Additionally, instructions for both types of affected platforms included to review the letter with each customer site's Medical Director or Laboratory Director and follow laboratory protocol regarding the need for reviewing previously reported patient results. If the product has been forwarded to other laboratories, please inform them of the recall and provide a copy of the notification letter. Also, complete and r
Quantity in commerce: 191,410 units total
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0798-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0798-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04
Z-0799-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-04

Product code CDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)