FDA-Device2025-08-06Class II

Blood/EMB, Levine 100/PK, Product Number R02041

Remel, Inc
Hazard

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Sold states
US Nationwide distribution.
Affected count
750 units
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
Blood/EMB, Levine 100/PK, Product Number R02041

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2025

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