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U.S. Department of Health and Human Services

Class 2 Device Recall GramPositive Blood Culture Control Panel (Inactivated Pellet)

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 Class 2 Device Recall GramPositive Blood Culture Control Panel (Inactivated Pellet)see related information
Date Initiated by FirmDecember 16, 2019
Create DateJanuary 16, 2020
Recall Status1 Terminated 3 on December 11, 2020
Recall NumberZ-0812-2020
Recall Event ID 84524
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductMicrobiologics 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.
Code Information Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52 
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactTechnical Support
320-253-1640
Manufacturer 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 2		Device Design
ActionRecall 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.
Quantity in Commerce810
DistributionDistributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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