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Recall Observatory FDA recall evidence

Device 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.

Z-0812-2020

December 16, 2019

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 84524
Status
Terminated
Classification
Class II
Quantity
810
Official record key
device-enforcement:Z-0812-2020

Official wording

Reason: 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.

Code information: Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52

Distribution pattern: Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.