Microbiologics Inc recalls Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used…

Recall date

December 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0812-2020

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.