FDA-Device2023-01-11Class II

PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

Biomerieux Inc
Hazard

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Sold states
US Nationwide distribution.
Affected count
60 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0871-2023

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