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Epoc® blood analysis bgem test cards

Official notice

18 Jul 2025

MediumHealth Canada

An official Health Canada notice concerns Epoc® blood analysis bgem test cards. Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some epoc® test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/l. The maximum bias observed was -14 mmol/l, which occurred at a higher sodium concentration around 150 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. Recall start date: July 9, 2025 Published 2025-07-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77740

Official notice

2025-07-18

The hazard

Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some epoc® test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/l. The maximum bias observed was -14 mmol/l, which occurred at a higher sodium concentration around 150 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. Recall start date: July 9, 2025

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

77740

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Affected products

Product 1

Affected products - epoc® Blood Analysis BGEM Test Cards, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 10736515

Risk / hazard

Siemens Healthcare Diagnostics Inc. Has confirmed that a negative sodium bias may exist in some epoc® test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/l. The maximum bias observed was -14 mmol/l, which occurred at a higher sodium concentration around 150 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. Recall start date: July 9, 2025

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® Blood Analysis Bgem Test Cards.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77740

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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