Z-0812-2020 Class II Terminated
FDA device recall Z-0812-2020 was initiated by Microbiologics Inc on December 16, 2019 and is designated Class II. 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… The recall status is terminated (terminated December 11, 2020). Affected quantity: 810.
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