Cepheid Xpert MRSA/MRSA NxG Control Panel — Class II medical device recall Z-1730-2019
Ongoing recall by Microbiologics Inc, reported 2019-06-12, distributed nationwide. Product with incorrect shelf life.
| Recall number | Z-1730-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2019-04-09 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, DE, GB, NZ |
| Quantity | 249 |
| UPC / GTIN / UDI-DI | 70845357041226 |
| Lot numbers | 8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, 8195-10, 8196-04, 8196-05, 8196-06, 8196-07, 8196-08, 8196-09, 8196-10, 8196-14 |
| Model numbers | 8195, 8196 |
Product
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.
Reason for recall
Product with incorrect shelf life.
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-1730-2019. 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.