Microbiologics recalls Gram-Positive Blood Culture Control Panels (Catalog #8180) due to incorrect hydration fluid specification. This may affect test accuracy in medical labs. No immediate action needed but verify your product model.
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.
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📍Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
✎ GovInfoNow plain-language explainer
Microbiologics is recalling Gram-Positive Blood Culture Control Panels (Catalog #8180) because the recommended hydration fluid changed from sterile saline or blood culture media to sterile DI water or phosphate buffer. This could affect test accuracy in medical labs if the wrong fluid is used. Read more at govinfonow.com/recall/66312-microbiologics-qc-sets-recall-wrong-hydration-fluid-risk.
“Microbiologics QC Sets Recall: Wrong Hydration Fluid Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66312-microbiologics-qc-sets-recall-wrong-hydration-fluid-risk. Based on FDA recall #Z-0812-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0812-2020%22&limit=1).
The FDA announced on 2019-12-16 that Microbiologics Inc is recalling its Microbiologics QC Sets and Panels, specifically the Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180. The hazard involves a change in the recommended hydration fluid for the product.
How to tell if you have it
Brand: Microbiologics
Product: Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
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.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since 2017-06-06. Other recent recalls of similar products include Microbiologics LYFO DISK recall (2025-12-02), Microbiologics KWIK-STIK Quality Control Kit Recall (2025-11-13), and Microbiologics LYFO-DISK recall (2025-06-27). Other recent recalls of similar products include Medline Blood Culture Kit Recall (2025-12-24), Bioporto ProNephro AKI Reagent Kit Recall (2026-05-18), and Medline Blood Culture Kits Recall (2026-03-16).
How to tell if you have this one
Check for the product name 'Gram-Positive Blood Culture Control Panel (Inactivated Pellet)' and catalog number 8180. The affected lot numbers are 8180-46 through 8180-52.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify your panel's catalog number and lot number to confirm if it's affected (catalog #8180, lots 8180-46 to 8180-52).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distributed nationwide including Washington DC, and distributed internationally to Germany and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0812-2020 (December 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0812-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.