Microbiologics QC Sets (Microbiologics) – hydration fluid change (2019)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
Products Sold
Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
Microbiologics Inc is recalling Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), C due to The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026