Pneumonia — Class II medical device recall Z-0844-2022
Terminated recall by Microbiologics Inc, reported 2022-04-06, distributed in AL, GA, IL, MT, PA, TN, TX, WI. Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
| Recall number | Z-0844-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2022-03-03 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Terminated | 2024-01-16 |
| Distributed | AL, GA, IL, MT, PA, TN, TX, WI |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 70845357043664 |
| Lot numbers | 8244 |
| Model numbers | 8244 |
Product
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
Reason for recall
Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.
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-0844-2022. 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.