FDA-Device2022-04-06Class II

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

Microbiologics Inc
Hazard

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

Sold states
US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin
Affected count
13 units
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2022

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