FDA Device recall Z-0023-2013
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Pr…
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Pr… by Biomerieux, citing the instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0023-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-28 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | US |
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
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Identifiers
| code_info | Serial numbers AS180-00001 to AS180-00376. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2013%22
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