Cepheid Xpert C — Class III medical device recall Z-1838-2019
Ongoing recall by Microbiologics Inc, reported 2019-06-26, distributed in CO, GA, MN, MO, NC, NH, NY, OH…. Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
| Recall number | Z-1838-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2019-05-16 |
| Classified | 2019-06-18 |
| Reported by FDA | 2019-06-26 |
| Distributed | CO, GA, MN, MO, NC, NH, NY, OH, PA, TN, TX |
| Quantity | 22 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 70845357041370 |
| Lot numbers | 8200-26 |
Product
Cepheid Xpert C. difficile/Epi Control Panel
Reason for recall
Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.
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-1838-2019. 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.