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Ih-500

Official notice

13 Oct 2022

Last checked

13 Oct 2022

Medium riskHealth Canada

An official Health Canada notice concerns Ih-500. In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e". Recall start date: September 23, 2022 Published 2022-10-13.

What to do now

Contact BIO-RAD LABORATORIES (CANADA) LTD. If you require additional information.

Recall number

72020

Official notice

2022-10-13

The hazard

In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e". Recall start date: September 23, 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

72020

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Affected products

Product 1

Affected products - IH-500, Lot or serial number - All lots., Model or catalogue number - 001500

Product 2

Affected products - Diaclon Abo/D+Reverse-Group, Lot or serial number - All lots., Model or catalogue number - 001236 001235 001234 001237

Product 3

Affected products - Diaclon Anti-N, Lot or serial number - All lots., Model or catalogue number - 00711

Product 4

Affected products - Diaclon Abd Confirmation For Donors, Lot or serial number - All lots., Model or catalogue number - 001135 001136 001134 001133

Product 5

Affected products - Diaclon Rh-Subgroup+K, Lot or serial number - All lots., Model or catalogue number - 002127 002125 002126 002124

Product 6

Affected products - Diaclon Anti-M, Lot or serial number - All lots., Model or catalogue number - 007011

Product 7

Affected products - Diaclon Abd Confirmation For Patients, Lot or serial number - All lots., Model or catalogue number - 001255 001256 001254 001257

Risk / hazard

In case of absence of red blood cells (RBC) sample into the anti-A well or anti-B well, the reading algorithm of the IH-500 might not be able to properly detect the dispense failure and return the result as positive instead of empty "e". Recall start date: September 23, 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: Diamed, Ih-500.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

72020

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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