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.
- Company
- Microbiologics Inc
- Recall Initiated
- December 16, 2019
- Terminated
- December 11, 2020
- Recall Number
- Z-0812-2020
- Quantity
- 810
- Firm Location
- Saint Cloud, MN
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
Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Lot / Code Info
Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
Root Cause
Device Design
Action Taken
Recall Letters was sent via email to all consignees regarding the correction on 12/16/2019 informing users of a new recommended hydration fluid which is reflected in labeling QC Sets and Panels: Technical Information TIB.2034 Rev G. Questions can be directed at Technical Support team at 1.320.229.7064 or techsupport@microbiologics.com . A response form is requested to be returned.