Microbiologics QC Sets and Panels — Class II medical device recall Z-0812-2020
Terminated recall by Microbiologics Inc, reported 2020-01-22, distributed nationwide. The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), h
| Recall number | Z-0812-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2019-12-16 |
| Classified | 2020-01-16 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, NL |
| Quantity | 810 |
| Reason classes | sterility |
| Lot numbers | 8180-46, 8180-47, 8180-48, 8180-49, 8180-50, 8180-51, 8180-52 |
| Model numbers | 8180 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0812-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.