Recall Z-1793-2020— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2020-01-24, terminated 2023-01-11. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-24
- Terminated
- 2023-01-11
- Firm location
- Durham, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.