Recall MonitorHealth Products
epoc® Blood Analysis BGEM Test Cards
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: epoc® Blood Analysis BGEM Test Cards
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| epoc® Blood Analysis BGEM Test Cards | More than 10 numbers, contact manufacturer. | 10736515 |
Issue
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc® test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/l. The maximum bias observed was -14 mmol/l, which occurred at a higher sodium concentration around 150 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. Recall start date: July 9, 2025