bioMerieux PREVI Isola Printer Power Supply Units Recalled for Fire Hazard
bioMerieux is recalling PREVI Isola printer power supply units due to a potential fire hazard. The affected units are distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a potential fire hazard, which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
bioMerieux, Inc. is recalling specific power supply units (PSUs) used in PREVI Isola Instruments and PREVI Isola Printers. The recall involves P1028888-001 PSUs, which are used in Zebra LP2824 Plus printers, with date codes ranging from 0639XX through 1253XX.
The recall was initiated because of a potential for overheating or a fire hazard associated with these power supply units. The affected products have been distributed worldwide, including in the United States and various international locations such as Australia, Belgium, China, Germany, Spain, France, Italy, Mexico, the Netherlands, Russia, Sweden, Finland, and South Africa.
Users of PREVI Isola instruments should check their equipment for the affected serial numbers listed in the recall notice. If the equipment matches the description, users should contact bioMerieux for instructions on how to proceed with the recall.
The recalled product
- 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).
- Manufacturer
- bioMerieux, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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