FDA Device recall Z-0799-2019
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle I…
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle I… by Abbott Ireland Diagnostics Division, citing 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 ARCHITE….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0799-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-12 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Ireland Diagnostics Division |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 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),…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0799-2019%22
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