Important Safety Alerts

Beckman Coulter has issued a medical device safety alert concerning the IRISpec CA/CB/CC control, manufactured by Iris Diagnostics. [Reference numbers: 800-7702 and 800-7702-FJR].

The manufacturer has become aware of an issue in which results for the IRISpec CB control for urobilinogen may fall below the lower limit of the stated quality control range.

The IRISpec CB control may intermittently fail for the urobilinogen analyte when run on the iChemVELOCITY. The customer's laboratory will be unable to process patient samples until quality control passes. This will not affect patient sample results.

A new lower limit on the urobilinogen control range is being implemented to align the published IFU range with that of the allowable product claims per Beckman Coulter's design requirements.

The IRISpec CA/CB/CC package insert (and strip package insert information related to controls) will be updated to reflect changes to the lower limit of the QC range.

Customers are recommended to take the following actions:

• Implement the use of the following revised quality control ranges for IRISpec CB urobilinogen for the iChemVELOCITY
• Refer to the iChemVELOCITY Operato's Manual (P/N 300-4449FE, Appendix A; Entering Consumables Data) to change the QC range or contact the manufacturer for assistance.
• Disregard any information related to control specifications that are outlined in strip package insert.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 30 August 2017