FDA recall Z-1793-2020

bioMerieux, Inc. · Class II · device

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.

Distribution

Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.

Key facts

Status
Terminated
Initiation date
2020-01-24
Report date
2020-04-29
Termination date
2023-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1793-2020