Food, drugs, devices › Bio-Rad Laboratories
Device recall: FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Micropl
FDA enforcement event 66293 is a device recall by Bio-Rad Laboratories of Redmond, WA, initiated 20 Aug 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 13 Nov 2013. Initiation: voluntary: firm initiated. Bio-Rad Laboratories has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Rad Laboratories, Redmond, WA.
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."
Distribution
"US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0032-2014 | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System. | 23 kits | Class III | Terminated | 30 Oct 2013 |
Context
Other enforcement events for Bio-Rad Laboratories
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Feb 2024 | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit | Device | Class II | 1 |
| 27 Jul 2012 | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitativ | Device | Class II | 1 |
All 3 events for Bio-Rad Laboratories
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Nov 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.