CLASS III Device recall · Reported 30 Oct 2013 · FDA Enforcement Report
FSE Image Upgrade Kit recalled by Bio-Rad Laboratories
Bio-Rad Laboratories is recalling FSE Image Upgrade Kit, distributed in 10 states. The recall was initiated on 20 Aug 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0032-2014
- FDA event ID
- 66293
- Recalling firm
- Bio-Rad Laboratories, Redmond, WA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Aug 2013
- FDA classified
- 21 Oct 2013
- Reported
- 30 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 20 Aug 2013 | Recall initiated by company | |
| 21 Oct 2013 | Classified by FDA | +62 days |
| 30 Oct 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Where it was distributed
US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
FloridaIowaMaineMissouriMississippiNebraskaNew YorkTennesseeTexasWashington
Questions about this recall
Why was it 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.
Which lots are affected?
Lot 122822
Where was it sold?
US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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