Recall Z-0812-2020
Microbiologics Inc · initiated December 16, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
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.
FDA-determined 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.
Details
- Recall number
- Z-0812-2020
- Initiated
- December 16, 2019
- Terminated
- December 11, 2020
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 810
- Distribution
- Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN