FDA-Device2021-11-24Class II

API 50 CH, Model 50300

bioMerieux, Inc.
Hazard

There is potential to provide an incorrect organism identification.

Sold states
Distribution in WI, NY, and SD
Affected count
1382 kits
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
API 50 CH, Model 50300

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2022

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