FDA Medical Device Recalls (openFDA)
Microbiologics Inc: 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.
- Recall number
- Z-0812-2020
- 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.
- Status
- Terminated
- Initiated
- 2019-12-16
- Posted
- not on file
- Terminated
- 2020-12-11
- 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.
- 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 techsupport@microbiologics.com . A response form is requested to be returned.
- Quantity
- 810
- Distribution
- Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.
- Lot, serial or model codes
- Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHQ
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28