Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors
Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (incorrect patient results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 7,415 units of the ARCHITECT Total T3 Reagent Kit (List Numbers 7K64-20 and 7K64-25). The recall affects Lot Numbers 38901UI00 and 38901UI01, which have an expiration date of January 29, 2015. The product is a chemiluminescent microparticle immunoassay used for the quantitative determination of total triiodothyronine in human serum and plasma.
The recall was initiated because 17% of the affected reagent lots may exhibit lower Relative Light Units (RLUs) than expected. This technical issue may result in controls being out of range or patient results being higher than expected. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected kits were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international countries. Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact Abbott Ireland Diagnostics Division for instructions on return or replacement.
The recalled product
- Product
- 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 Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 ac
- Manufacturer
- Abbott Ireland Diagnostics Division
- Hazard
- Affected units
- 7,415
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Product List Numbers
- Lot Numbers
- and Expiration Dates: 1) List Number: 7K64-20
- Lot Number 38901UI00
- Expires: 29-Jan-15
- 2) List Number: 7K64-25
- Lot Number 38901UI01
Distribution
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