Irispec Ca/Cb/Cc

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent Irispec Cb glucose control false positive results when used in conjunction with ichemvelocity urine chemistry strips PN 800-7212. If a QC run fails, the system will not allow the operator to run patient samples. the QC run should be repeated and be successful before running patient samples ([ichemvelocity urine chemistry system instructions for use (IFU) P/N 301-7146be, chapter 4; quality control). This issue affects Irispec Cb control lot numbers 565-22 and higher when analyzed with ichemvelocity urine chemistry strips (pn 800-7212) lot numbers 7212554m and higher. There is no impact to patient results, Irispec Ca or Cc controls. 

Recall start date: November 14, 2022