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.
Z-0812-2020
Product summary
- Event
- Event 84524
- Status
- Terminated
- Classification
- Class II
- Quantity
- 810
- Official record key
device-enforcement:Z-0812-2020
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.