Cepheid Respiratory Control Panel Catalog #8199 for in vitro… — Class II medical device recall Z-0982-2019
Terminated recall by Microbiologics Inc, reported 2019-03-13, distributed nationwide. Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 mo
| Recall number | Z-0982-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2019-01-31 |
| Classified | 2019-03-07 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, FI, GB, IE, MY, NZ, PT, SE, ZA |
| Quantity | 704 units |
| Lot numbers | 8199-02, 8199-03, 8199-04, 8199-05, 8199-06, 8199-07, 8199-08, 8199-09, 8199-10, 8199-11, 8199-12, 8199-13, 8199-17, 8199-18, 8199-19 |
| Model numbers | 8199 |
Product
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Reason for recall
Cepheid Xpert Respiratory Control Panel (Catalog #8199) has an reduced expiration date from 24 months to 13 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-0982-2019. 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.