No image published for this recall

No image published for this recall

Irispec ca cb cc

Official notice

26 Jul 2024

Last checked

26 Jul 2024

Medium riskHealth Canada

An official Health Canada notice concerns Irispec ca cb cc. Beckman Coulter has become aware of an increase in complaints for intermittent IRISpec CB failures for ketone on the iChemVELOCITY Urine Chemistry System (instructions for use PN 300-4449FH) and DxU 810c IRIS Urine Chemistry System (instructions for use PN C49355AA). If a QC run fails, the system will not allow the operator to run patient samples. The QC run should be repeated and pass successfully before running patient samples. Recall start date: July 16, 2024 Published 2024-07-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75875

Official notice

2024-07-26

The hazard

Beckman Coulter has become aware of an increase in complaints for intermittent IRISpec CB failures for ketone on the iChemVELOCITY Urine Chemistry System (instructions for use PN 300-4449FH) and DxU 810c IRIS Urine Chemistry System (instructions for use PN C49355AA). If a QC run fails, the system will not allow the operator to run patient samples. The QC run should be repeated and pass successfully before running patient samples. Recall start date: July 16, 2024

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.

Recall Numbers

75875

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Affected products

Product 1

Affected products - IRISpec CA/CB/CC, Lot or serial number - 432-24 and higher, Model or catalog number - 800-7702

Risk / hazard

Beckman Coulter has become aware of an increase in complaints for intermittent IRISpec CB failures for ketone on the iChemVELOCITY Urine Chemistry System (instructions for use PN 300-4449FH) and DxU 810c IRIS Urine Chemistry System (instructions for use PN C49355AA). If a QC run fails, the system will not allow the operator to run patient samples. The QC run should be repeated and pass successfully before running patient samples. Recall start date: July 16, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Beckman Coulter Ireland, Irispec Ca Cb Cc.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75875

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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