PREVI Isola Insrument and PREVI Isola Printer spares PSUs recalled over fire hazard

Recall date

January 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

bioMerieux, Inc. recalls PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824…

Recall number

Z-1793-2020

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).