Z-0855-2007

ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30...

Name: Z-0855-2007 ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30...
Creator: Abbott Laboratories MPG
Published: 2007-03-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-03-08 / Terminated

FDA source

Abbott Laboratories MPG began a recall of 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... on 2007-03-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0855-2007
Status: Terminated
Initiated: 2007-03-08
Posted: 2007-06-14
Terminated: 2008-07-16
Recalling firm: Abbott Medical
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
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: 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
FDA root cause: Other
Action: 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.
Quantity in commerce: 9,438 kits
Distribution: Worldwide: USA including Puerto Rico, and internationally to Canada, Brazil, Germany, Japan, Taiwan, Hong Kong, Thailand, South Korea, Australia, New Zealand, Mexico, Colombia, Chile, Argentina and Trindad & Tobago.
Product codes and lots: Lot numbers 11455C006, 11605UN06, 12072UN06, 14818UN06, 13037UN06, 12990UN06, 12982UN06, 11456C006, 11609UN06, 14817UN06, 14339UN06, 13590UN06, 12986UN06, 14350UN06, 13122UN06, 12978UN06, 11370C006

Product code MMI

K041192Class IIArchitect Stat Troponin-I ImmunoassayFisher Diagnostics / cleared 2004-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)