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.
This recall has been terminated (originally issued December 16, 2019).
- Company
- Microbiologics Inc
- Recall Initiated
- December 16, 2019
- Terminated
- December 11, 2020
- Recall Number
- Z-0812-2020
- Quantity
- 810
- Firm Location
- Saint Cloud, MN
- Official Source
- View on FDA website ↗
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.