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VITROS Chemistry Product System-Ca Slides (Calcium) Recall Due to Generations...

# Major Recall Alert: VITROS Chemistry Product System-Ca Slides (Calcium) Recalled Due to Calibration Issues on Generations 67 and Above

On **July 14, 2025**, an important recall was announced for the **VITROS Chemistry Product System-Ca Slides (Calcium)**. This affects Generations (Gens) 67 and above of VITROS CA slides used in the **VITROS XT 3400 and VITROS XT 7600 systems**. The recall was initiated due to an increased occurrence of **Condition Code th4-63j** during calibration. This condition code occurs when the reflectometer detects image variations exceeding parameters defined on the assay data disk (ADD), leading to calibration failures that could impact assay accuracy.

If you use VITROS systems in a healthcare or laboratory setting, this recall is crucial to ensure continued accuracy in calcium slide testing.

For the official recall notice and updates, visit the **[Health Canada recall page](https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-product-system-ca-slides-calcium)**.

## Why This Recall is Important

This recall has significant implications for diagnostic testing. Improper calibration caused by **Condition Code th4-63j** can result in:

- **Failed test accuracy:** Unreliable calcium testing could compromise diagnostic outcomes.
- **Disrupted workflows:** Calibration errors can slow down lab operations, leading to delays.
- **Potential health risks:** Inaccurate calcium testing might lead to missed or incorrect diagnoses for patients.

The affected slides are specifically used on **VITROS XT 3400** and **VITROS XT 7600 systems**, common equipment in medical laboratories. Healthcare professionals and lab technicians must take immediate action to address potential equipment-related disruptions.

## Details of the Recall

Here’s a quick breakdown of everything you need to know about this recall:

- **Product Name:** VITROS Chemistry Product System-Ca Slides (Calcium)
- **Affected Generations:** Slides Generations (Gens) 67 and above
- **Issue:** Increased occurrence of **Condition Code th4-63j** during calibration on VITROS XT 3400 and VITROS XT 7600 systems
- **Cause:** Image variations exceeding assay parameters set on the assay data disk (ADD)
- **Consequence:** Calibration failure, potentially leading to unreliable test results
- **Recall Start Date:** July 14, 2025
- **Brand:** VITROS Chemistry Product System-Ca

For complete information, refer to the **[official recall alert from Health Canada](https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-product-system-ca-slides-calcium)**.

## What You Should Do

If your laboratory or clinic uses this product, follow these steps immediately:

1. **Identify the affected product:** Check if you are using Generations 67 and above of the VITROS Chemistry Product System-Ca Slides.
2. **Review calibration performance:** Monitor your VITROS XT 3400 or XT 7600 systems for Condition Code th4-63j errors.
3. **Stop using affected slides:** Avoid using the impacted slides until the manufacturer provides updated guidance.
4. **Contact your supplier or manufacturer:** Request support for replacement slides or technical assistance.
5. **Notify all relevant personnel:** Ensure that lab staff and technicians are aware of the recall and adjust workflows as needed.

Timely action is critical to maintaining test accuracy and preventing diagnostic interruptions.

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For more information on this recall, visit the official **[Health Canada recall page](https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-product-system-ca-slides-calcium)**.

## Final Thoughts

The recall of VITROS Chemistry Product System-Ca Slides due to calibration issues highlights the importance of proactive monitoring and compliance in diagnostic operations. Labs and clinics using this equipment must prioritize immediate action to ensure the reliability of their calcium testing procedures. Always stay updated on recalls to safeguard the accuracy of your systems and the health of your patients.

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