Microbiologics Inc: Medical Device Recall in 2020 - (Recall #: Z-0812-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 16, 2019

Date Posted: January 22, 2020

Recall Number: Z-0812-2020

Event ID: 84524

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.

Status: Terminated

Product Quantity: 810

Code Information:

Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated