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Epoc bgem bun test card [25pk]

Official notice

4 Oct 2024

MediumHealth Canada

An official Health Canada notice concerns Epoc bgem bun test card [25pk]. Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some card lots approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/l. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. Please note the card lots identified are now expired. Recall start date: September 25, 2024 Published 2024-10-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76285

Official notice

2024-10-04

The hazard

Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some card lots approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/l. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. Please note the card lots identified are now expired. Recall start date: September 25, 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

76285

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Affected products

Product 1

Affected products - Epoc Bgem Bun Test Card [25pk], Lot of serial number - 08-24092-60, Model or catalogue number - 10736515

Risk / hazard

Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some card lots approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/l. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. Please note the card lots identified are now expired. Recall start date: September 25, 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: Epocal, Epoc Bgem Bun Test Card [25pk].

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76285

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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