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Irispec ca cb cc
Official notice
25 Nov 2022
Last checked
25 Nov 2022
An official Health Canada notice concerns 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 Published 2022-11-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72217
Official notice
2022-11-25
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
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Company & contacts
Brand: Beckman Coulter Ireland, Irispec Ca Cb Cc.
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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