FDA Device recall Z-0812-2020
Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to e…
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to e… by Microbiologics, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0812-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-16 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microbiologics |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot # 8180-46 8180-47 8180-48 8180-49 8180-50 8180-51 8180-52 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0812-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.