FDAFDA · Food and drugs·Recall number Z-0812-2020
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.
Published January 22, 2020 · Recall initiated: December 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
- Lot
- Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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