Reported Dec 3, 2014 · Terminated
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated…
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 · N/A
Is this the product you have?
- ARCHITECT
- Total T3 Reagent Kit (7K64) consists of- 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers
- Minimum Concentration0.08% solids
- PreservativeProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers
- Minimum concentration0.33 ng/mL
- PreservativeProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma
- Lot codes and dates
- Product List Numbers, Lot Numbers
- and Expiration Dates1)
- List Number
7K64-20Lot Number 38901UI00
- Expires
29-Jan-152)
- List Number
7K64-25Lot Number 38901UI01
- Expires29-Jan-15
- Amount recalled
- 7,415 kits
Where it was sold
Why it was recalled
17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected.
This product could cause temporary or reversible health problems — stop using it.
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