# FDA recall Z-0798-2019

> **Abbott Ireland Diagnostics Division** · Class II · device recall initiated 2018-10-12.

## 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.

## 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

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, 

## Key facts

- **Recall number:** Z-0798-2019
- **Recalling firm:** Abbott Ireland Diagnostics Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-12
- **Report date:** 2019-02-13
- **Termination date:** 2020-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Co. Longford, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0798-2019

## Citation

> AI Analytics. FDA recall Z-0798-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0798-2019. Source: US FDA. Licensed CC0.

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