Abbott Laboratories MPG ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
Products Sold
Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006
Abbott Laboratories MPG is recalling ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2 due to False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT T. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Negative Results : The analytical sensitivity claim of less than or equal to 0.01 ng/mL (ug/L) might not be met for all lots of Architect STAT Troponin-I reagents, thus false negative results may occur with negative results less than 0.1 ng/mL
Recommended Action
Per FDA guidance
Abbott sent a Product Correction letter on 3/8/07 to all Troponin-I customers who received reagent lots in the last 12 months. The letters informed the accounts that the analytical sensitivity claim of = 0.01 ng/mL might not be met for all lots of Architect STAT Troponin-I reagents. The accounts were directed to evaluate the information the information provided in the letter against the reference range used in their laboratory to determine if any action needs to be taken; to follow their facility's policies and procedures for communicating with the heath care providers they serve; to forward a copy of the letter to any laboratory to whom they may have forwarded the reagent; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT in the U.S. A follow-up press release was issued on 5/25/07 and a follow-up letter was issued on 5/29/07, providing updated instructions for laboratories to follow when using the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026