# Major Recall Alert: cobas® c 303 Analytical Unit, cobas® c 503 Analytical Unit, cobas® pro Sample Supply Unit, cobas® pure Sample Supply Unit Recalled Due to Rare Software Malfunction Impacting Calibration Library
A major recall has been issued for the cobas® c 303 and c 503 analytical units, as well as the cobas® pro and cobas® pure sample supply units. A rare software malfunction affecting the calibration library has been identified. This defect, which occurs only in cobas® pro software version <03-01 and cobas® pure software version <01-04, impacts assays utilizing spline-type calibration. This recall highlights the importance of addressing potential risks associated with laboratory testing equipment.
Read on for crucial details about this recall, why it matters, and what steps you can take to mitigate potential risks.
## Why This Recall is Important
Ensuring accuracy in laboratory results is critical when it comes to patient care and diagnostics. The identified software malfunction in the cobas® platforms could jeopardize the reliability of spline-type calibration assays, thereby posing a significant risk to laboratory operations and patient outcomes. Calibration errors in assays can lead to inaccurate test results, possibly affecting medical diagnoses and treatment plans.
While the defect is described as "rare," it’s essential for affected users to take this recall seriously and follow recommended safety measures to avoid the potential risks associated with this malfunction.
## Details of the Recall
Here are the key details of the cobas® recall:
- **Category**: CAN (Canada)
- **Products Affected**:
- Cobas® c 303 analytical unit
- Cobas® c 503 analytical unit
- Cobas® pro sample supply unit
- Cobas® pure sample supply unit
- **Problem Identified**: Rare software malfunction in the calibration library.
- **Affected Software Versions**:
- cobas® pro software version <03-01
- cobas® pure software version <01-04
- **Issue**: Impacts assays utilizing spline-type calibration.
- **Date Announced**: October 2023
The identified malfunction is specific to the calibration library in older versions of the cobas® software, so users running up-to-date software may not be impacted.
For more official information, visit the **[official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/cobasr-pro-and-cobasr-pure)**.
## What You Should Do
If you use any of the affected cobas® platforms in your laboratory, take the following steps immediately:
- **Check Your Software Version**:
Identify whether your cobas® pro or cobas® pure software versions are affected (cobas® pro <03-01 or cobas® pure <01-04).
- **Upgrade Your Software**:
Ensure your cobas® platform is updated to the latest software version to minimize risks associated with the malfunction.
- **Follow Guidance from the Manufacturer**:
Contact the manufacturer for instructions on obtaining updates and confirm proper calibration practices.
- **Disseminate Information**:
Inform your laboratory team and any relevant stakeholders about the recall to ensure compliance and safety moving forward.
Taking these proactive measures can help safeguard the accuracy and reliability of your diagnostic equipment.
## Stay Safe – Get Instant Recall Alerts
Keeping track of recalls is essential for patient safety, operational integrity, and regulatory compliance. Stay ahead of potential hazards by downloading our recall alert app. With real-time notifications, you’ll never miss critical updates about products that matter to you.
**[Download the Recall App Now](#)** and stay informed of recalls impacting laboratory equipment, electronics, and more.
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Reliable patient diagnostics depend on accurate and safe equipment. This cobas® recall emphasizes the importance of staying vigilant and up-to-date on software updates. For complete details, visit the official recall notice **[here](https://recalls-rappels.canada.ca/en/alert-recall/cobasr-pro-and-cobasr-pure)**.