Z-0812-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- December 16, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 810
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.
Distribution Pattern
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