Recall Z-0798-2019 ยท CDP Radioimmunoassay, Total Triiodothyronine
Abbott Ireland Diagnostics Division
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.
| Date | Oct 12, 2018 |
| Status | Terminated |
| Reason | 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 | 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 rH |
| Quantity | 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, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.