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Microbiologics Inc recalls Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used
Recalled January 22, 2020 · FDA recall Z-0812-2020 · Microbiologics
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. · FDA Class II
Units
810
Sold at
Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Description
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.
Product
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.
Manufacturer(s)
Microbiologics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →