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Epoc blood analysis system - single use blood gas, electrolyte and metabolite test card
Official notice
15 Jun 2023
An official Health Canada notice concerns Epoc blood analysis system - single use blood gas, electrolyte and metabolite test card. Siemens Healthcare Diagnostics Inc. Has confirmed the occurrence of discrepant high glucose results in samples with glucose results on the lower end of the reportable range (at or below 54 mg/dl) when using the above listed lots of BGEM test cards in conjunction with sensor configuration 41.1 (software version: EPOC Host v3.37.3 and EPOC NXS v4.10.6). The observed maximum bias for the affected lots are detailed in the urgent field safety notice. Recall start date: June 5, 2023 Published 2023-06-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73827
Official notice
2023-06-15
The hazard
The hazard
Siemens Healthcare Diagnostics Inc. Has confirmed the occurrence of discrepant high glucose results in samples with glucose results on the lower end of the reportable range (at or below 54 mg/dl) when using the above listed lots of BGEM test cards in conjunction with sensor configuration 41.1 (software version: EPOC Host v3.37.3 and EPOC NXS v4.10.6). The observed maximum bias for the affected lots are detailed in the urgent field safety notice. Recall start date: June 5, 2023
How to check if you're affected
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.
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Epocal, Epoc Blood Analysis System - Single Use Blood Gas Electrolyte And Metabolite Test Card.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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