Recall Monitor
Health Products

epoc Blood Analysis BGEM Test Card

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: epoc Blood Analysis BGEM Test Card
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Epoc Blood Analysis Bgem Test CardLot with prefix 02 or 1210736515
Epoc Blood Analysis System - Single Use Blood Gas, Electrolyte And Metabolite Test Card10736382, Lot prefix 00 or 06CT-1006-00-00

Issue

Siemens confirmed that the occurrence of discrepant high pH results in samples introduced with higher injection volumes (beyond the epoc reader beep or after the "analyzing sample" message is displayed) with epoc sensor configuration 45.n (software version: epoc host v3.41.2 and epoc nxs v4.14.9 & 4.14.11) Recall start date: March 25, 2025

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