Reported Oct 30, 2013 · Terminated

FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS…

Bio-Rad Laboratories

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories · 6565 185th Ave NE · Redmond, WA · 98052-5039

Is this the product you have?

  • FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Lot codes and dates
  • Lot 122822
Amount recalled
23 kits

Where it was sold

Why it was recalled

The FSE Image Upgrade kit (part 92019C) is recalled due to 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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 13, 2013 · Data as of Sep 19, 4:47 PM UTC

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