RAPIDLab® 348EX System Recall

Source: Health Canada · Canada

Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.

Health Canada reports a recall for the RAPIDLab® 348EX System due to a software issue with calcium ion concentration results when connected to a Laboratory Information System.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on August 1, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.

What Happened

Siemens Healthcare is informing affected customers that a software-related behavior identified in the RAPIDLab® 348EX System associated with the calcium ion concentration adjusted to H 7.4 result when the instrument is connected to a Laboratory Information System (LIS).

Which Products Are Affected

  • RAPIDLab® 348EX System, serial B777, model RAPIDLAB348EX
  • RAPIDLab® 348EX System, serial D065, model RAPIDLAB348EX
  • RAPIDLab® 348EX System, serial E457, model RAPIDLAB348EX

What You Should Do

Siemens Healthcare is informing affected customers of the issue.

Why This Matters

The software behavior may affect calcium ion concentration results transmitted via Laboratory Information System connections.

Source

Health Canada

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Health Canada reports a recall for the RAPIDLab® 348EX System due to a software issue with calcium ion concentration results when connected to a Laboratory Information System.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.