Reported Feb 13, 2019 · Terminated
ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a…
Abbott Ireland Diagnostics Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Ireland Diagnostics Division · Lisnamuck · Co. Longford · N/A
Is this the product you have?
- ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or
- i2000/i2000SR platforms Product UsageIt is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma
- Lot codes and dates
- 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
- Amount recalled
- 191,410 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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