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.
FDA Recall Z-0812-2020 · Posted None
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Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2019-12-16
Date Terminated2020-12-11
Product Quantity810
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.
Firm Action
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 [email protected] . A response form is requested to be returned.
Root Cause
Device Design
Distribution Pattern
Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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