ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Us...
FDA Device Recall #Z-0799-2019 — Class II — October 12, 2018
Recall Summary
| Recall Number | Z-0799-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abbott Ireland Diagnostics Division |
| Location | Co. Longford |
| Product Type | Devices |
| Quantity | 191,410 units total |
Product Description
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.
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.
Lot / Code Information
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.
Other Recalls from Abbott Ireland Diagnostics Division
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1353-2019 | Class II | Abbott ARCHITECT Estradiol Reagent Kit - Produc... | Feb 5, 2019 |
| Z-1354-2019 | Class II | Abbott Alinity i Estradiol Reagent Kit - Produc... | Feb 5, 2019 |
| Z-0668-2019 | Class II | Alinity i Progesterone Reagent Kit, List Number... | Nov 21, 2018 |
| Z-0666-2019 | Class II | Alinity i Total Beta-hCG Reagent Kit, List Numb... | Nov 21, 2018 |
| Z-0667-2019 | Class II | Alinity i Estradiol Reagent Kit, List Number 07... | Nov 21, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.