PREVI Isola Insrument and PREVI Isola Printer spares PSUs — Class II medical device recall Z-1793-2020
Terminated recall by bioMerieux, Inc., reported 2020-04-29, distributed nationwide. The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP28
| Recall number | Z-1793-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2020-01-24 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2023-01-11 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Serial numbers | 1000283, 1007580, 1007884, 1011691, 1029148, 1029262, 1029272, 1029990, 1030890, 1031472, 1031886, 1033400, 1033454, 1034034, 1034190, 1034363, 1035196, 1035549, 1035594, 1039290, 1039588, 1039938, 1040343, 1041241, 1042188 and 65 more |
Product
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
Reason for recall
The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
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-1793-2020. 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.