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Terminated

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.

FDA Recall Z-0798-2019 · Posted None

Recalling FirmAbbott Ireland Diagnostics Division
Recall StatusTerminated
Product CodeCDP
Date Initiated2018-10-12
Date Terminated2020-12-14
Product Quantity191,410 units total

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.

Firm 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

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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