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Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet)...

FDA Recall #Z-0812-2020 — Class II — December 16, 2019

Recall #Z-0812-2020 Date: December 16, 2019 Classification: Class II Status: Terminated

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.

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.

Recalling Firm

Microbiologics Inc — Saint Cloud, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

810

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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