Z-1509-2012

ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit...

Name: Z-1509-2012 ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit...
Creator: Abbott Laboratories
Published: 2012-04-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-04-11 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles... on 2012-04-11. The reason FDA records is "The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1509-2012
Status: Terminated
Initiated: 2012-04-11
Posted: 2012-05-10
Terminated: 2016-12-23
Recalling firm: Abbott Medical
Product: ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Abbott Laboratories, sent a "Product Recall Immediate Action Required"letter dated April 11, 2012 to all Troponin-I customers who received the affected reagent lot internationally. The customers were directed to determine if they are currently using and/or have inventory of lot 74264UN11; to discontinue use and destroy any remaining inventory of the lot; 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; to retain a copy of the letter for their records and to complete and return the Customer Reply Form (sent to Abbott international affiliates via e-mail on 4/11/2012) via fax to: 1-800-777-0051 or e-mail: [email protected]. Any questions were directed to their local Customer Service representative or call the field action coordinator at 847-938-1923 or email: [email protected].
Quantity in commerce: 8,723 kits
Distribution: International distribution only: including countries of: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia & Herze, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Mali, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
Product codes and lots: list number 2K41-28, lot number 74264UN11, expiration date 31OCT12

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)