Reported Sep 7, 2022 · Ongoing
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
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 Troponin-I Reagent Kit, REF 2K41-27
- Lot codes and dates
- UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22
- Amount recalled
- 2451 kits of 100 tests
Where it was sold
- Nationwide
Why it was recalled
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
This product could cause temporary or reversible health problems — stop using it.
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