FDA recall Z-0812-2020

Microbiologics Inc · Class II · device

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-12-16
Report date
2020-01-22
Termination date
2020-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2020