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Epoc blood analysis bgem test cards

Official notice

20 Jun 2022

MediumHealth Canada

An official Health Canada notice concerns Epoc blood analysis bgem test cards. Siemens Healthcare Diagnostics Inc. Has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. At a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-250 mmhg). Recall start date: June 8, 2022 Published 2022-06-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64288

Official notice

2022-06-20

The hazard

Siemens Healthcare Diagnostics Inc. Has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. At a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-250 mmhg). Recall start date: June 8, 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

64288

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Affected products

Product 1

Affected products - Epoc Blood Analysis Bgem Test Cards, Lot or serial number - 112200550, Model or catalog number - 10736515

Risk / hazard

Siemens Healthcare Diagnostics Inc. Has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. At a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-250 mmhg). Recall start date: June 8, 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: 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

64288

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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