Recall Z-0798-2019— Abbott Ireland Diagnostics Division
Class II · Terminated
Class II FDA medical device recall by Abbott Ireland Diagnostics Division, initiated 2018-10-12, terminated 2020-12-14. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Abbott Ireland Diagnostics Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-12
- Terminated
- 2020-12-14
- Firm location
- Co. Longford, Ireland
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.