Epoc Bgem Bun Test Card [25pk]
Brand(s)
Last updated
Summary
Product
Epoc Bgem Bun Test Card [25pk]
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
Affected products |
Lot of serial number |
Model or catalogue number |
|---|---|---|
Epoc Bgem Bun Test Card [25pk] |
08-24092-60 |
10736515 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Epocal Inc. |
| 2060 Walkley Road, Ottawa, Ontario, Canada, K1G 3P5 |
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76285
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