Reported Apr 10, 2024 · Ongoing
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Abbott Laboratories
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Laboratories · 100 Abbott Park Rd Bldg Ap8b · Abbott Park, IL · 60064-3502
Is this the product you have?
- ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
- Lot codes and dates
- LN 2K43-25 - Lot number 50808UN23, exp. 11/30/2024, UDI (01)00380740003302 (17)241130(10)50808UN23; LN 2K43-20 - Lot number 60104UN23, exp. 11/30/2024, UDI (01)00380740003296 (17)241130(10)60104UN23.
- Amount recalled
- 7482 kits
Where it was sold
Why it was recalled
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.
This product could cause temporary or reversible health problems — stop using it.
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