PREVI Isola System — Class II medical device recall Z-0023-2013
Terminated recall by Biomerieux Inc, reported 2012-10-17, distributed nationwide. The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
| Recall number | Z-0023-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2012-08-28 |
| Classified | 2012-10-09 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2014-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 350 systems |
| Serial numbers | AS180-00001, AS180-00376 |
| Model numbers | 29500, 29500R |
Product
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Reason for recall
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
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-0023-2013. 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.