No image published for this recall

No image published for this recall

Irispec ca cb cc

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada

An official Health Canada notice concerns Irispec ca cb cc. Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be successful before running patient specimens. This issue affects Irispec Ca control lot number 583-21 and higher when analyzed with ichemvelocity urine chemistry strips lot number 7212510m and higher. There is no impact to patient results, Irispec Cb or Cc controls. Recall start date: Feb 14, 2022 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63984

Official notice

2022-03-14

The hazard

Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be successful before running patient specimens. This issue affects Irispec Ca control lot number 583-21 and higher when analyzed with ichemvelocity urine chemistry strips lot number 7212510m and higher. There is no impact to patient results, Irispec Cb or Cc controls. Recall start date: Feb 14, 2022

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

63984

Lots

583-21, higher, 7212510m

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Affected products

Product 1

Affected Products - Irispec Ca/Cb/Cc, Lot or Serial Number - CA control 583-21 and higher, Model or catalog number - 800-7211

Risk / hazard

Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be successful before running patient specimens. This issue affects Irispec Ca control lot number 583-21 and higher when analyzed with ichemvelocity urine chemistry strips lot number 7212510m and higher. There is no impact to patient results, Irispec Cb or Cc controls. Recall start date: Feb 14, 2022

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

63984

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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