Z-0812-2020Class II

Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog #...

Name: Z-0812-2020 Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog #...
Creator: Microbiologics Inc
Published: 2019-12-16
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2019-12-16 / Terminated / root cause: design

FDA source

Microbiologics Inc began a recall of Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test... on 2019-12-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0812-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Posted: 2020-01-16
Terminated: 2020-12-11
Recalling firm: Microbiologics, Inc.
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.
Product code: OHQ Multi-Analyte Controls Unassayed
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 810
Distribution: Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
Product codes and lots: Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0812-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-16

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)