FDA-Device2020-01-22Class II
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Microbiologics Inc
Hazard
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer.
Sold states
Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Affected count
810
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2020Don't want to check this manually?
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