Public recall detail

Epoc Bgem Bun Test Card [25pk]

2024-10-04

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Recall Safety notice
Quick summary

Quick summary: Epoc Bgem Bun Test Card [25pk]. Date: 2024-10-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Epoc Bgem Bun Test Card [25pk]. Date: 2024-10-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEpocal Inc.
ProductEpoc Bgem Bun Test Card [25pk]
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76285

Affected products

ProductEpoc Bgem Bun Test Card [25pk]
Lot08-24092-60
Model10736515
Serial number08-24092-60
DescriptionEpoc Bgem Bun Test Card [25pk]

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesEpocal Inc. 2060 Walkley Road, Ottawa, Ontario, Canada, K1G 3P5
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76285
Background{}
CompaniesEpocal Inc. 2060 Walkley Road, Ottawa, Ontario, Canada, K1G 3P5
AudiencesHealthcare Industry
Source updated2024-10-04

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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