Bio-Rad Recalls FSE Image Upgrade Kits Due to Data Export Issues
Bio-Rad Laboratories is recalling 23 FSE Image Upgrade Kits because of a software issue that affects data export from the EVOLIS analyzer to Laboratory Information Systems.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a software data export error rather than a direct physical hazard.
Plain-English summary
Bio-Rad Laboratories is recalling 23 units of the FSE Image Upgrade Kit (Catalog # 92019C). This kit is used to install or upgrade software for the EVOLIS Microplate System.
The recall is due to an issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
The affected kits were distributed in the United States, including the states of Florida, Iowa, Maine, Missouri, Mississippi, Nebraska, New York, Tennessee, Texas, and Washington. The specific lot number is 122822.
The recalled product
- Product
- FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
- Manufacturer
- Bio-Rad Laboratories
- Hazard
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 122822
Distribution
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