Abbott ARCHITECT STAT Myoglobin Reagent Kit recalled due to manufacturing defect
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
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: FDA Class II recall with no reported illnesses or injuries. The defect poses risk of delayed diagnosis of myocardial infarction (a serious health condition) with no harm yet reported, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Abbott Laboratories is recalling 7,482 ARCHITECT STAT Myoglobin Reagent Kit units due to a manufacturing defect. The affected kits are Lot Number 2K43-25 (lot 50808UN23) and Lot Number 2K43-20 (lot 60104UN23), both with an expiration date of November 30, 2024.
The recall was initiated because of a manufacturing issue in which microparticles did not meet the labeled specification. This defect caused failure of the kit's calibration and quality control measures, which may result in incorrect myoglobin test results and delayed diagnosis of myocardial infarction (heart attack).
These kits were distributed worldwide, with domestic distribution across 20 U.S. states including Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, and Wisconsin. International distribution included 38 countries.
The recalled product
- Product
- ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
- Manufacturer
- Abbott Laboratories
- Hazard
- incorrect-test-results
- delayed-diagnosis
- manufacturing-defect
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 (5)
- LN 2K43-25 - Lot number 50808UN23
- exp. 11/30/2024
- UDI (01)00380740003302 (17)241130(10)50808UN23
- LN 2K43-20 - Lot number 60104UN23
- UDI (01)00380740003296 (17)241130(10)60104UN23.
Distribution
Distributed nationwide across the United States.
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