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VITEK 2 Compact 30 Systems, VITEK 2 Compact 60 System, VITEK 2 System Recall ...

# Major Recall Alert: VITEK 2 Compact 30 Systems, VITEK 2 Compact 60 System, and VITEK 2 System Recalled Due to Antibiotic Testing Issues

BioMérieux has issued a significant recall for VITEK 2 Compact 30 Systems, VITEK 2 Compact 60 Systems, and VITEK 2 Systems across Canada. The recall stems from increased out-of-range high-quality control results and inaccurate antibiotic susceptibility testing for specific formulations. These errors could lead to false resistance diagnoses for Enterobacterales/Enterobacteriaceae and *P. aeruginosa*, raising serious patient safety concerns.

Discover more about the implications, products affected, and safety measures being enforced to address this urgent issue.

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## Why This Recall is Important

Accurate microbial susceptibility testing is critical in determining appropriate treatment for bacterial infections. In this recall, BioMérieux has flagged issues with five antibiotic formulations used in testing on the VITEK 2 systems:

- Ceftazidime/avibactam (CZA02n)
- Imipenem (IPM05n)
- Imipenem/relebactam (IPR01n)
- Meropenem/vaborbactam (MEV01n)
- Polymyxin B (PB02n)

The identified problem also involves errors on the VITEK® 2 GN-AST cards that yield false resistance results when testing Enterobacterales/Enterobacteriaceae and *Pseudomonas aeruginosa*.

False resistance results can lead to:
- Incorrect antibiotic use, affecting treatment outcomes
- Delayed recovery times for patients
- A potential rise in adverse health events
- Further public health concerns, especially in hospital environments

Due to the critical nature of this issue, it is vital for healthcare providers and laboratories to act promptly to mitigate risks to patient care.

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### Details of the Recall

**Category:** Medical Device - Laboratory Testing Equipment
**Brand:** VITEK 2 Systems
**Models Involved:**
- VITEK 2 Compact 30 Systems
- VITEK 2 Compact 60 Systems
- VITEK 2 Systems

**Date Announced:** October 12, 2023
**Problem Identified:**
- Increased out-of-range high-quality control results for key antibiotic formulations (listed above)
- False resistance results on VITEK® 2 GN-AST cards when testing key bacterial species

More information is available in the [official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/vitekr-2-systems).

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### What You Should Do

If your facility uses the affected VITEK 2 systems, the following precautionary steps are recommended:

1. **Cease Use of Affected Models:** Immediately halt the use of VITEK 2 Compact 30, Compact 60, and standard systems until further updates from BioMérieux.
2. **Contact BioMérieux:** Report all issues encountered and seek guidance on adjustments to testing protocols.
3. **Review Test Results:** Assess recent testing results involving affected antibiotic formulations to identify potential inaccuracies.
4. **Notify Healthcare Providers:** Inform medical teams promptly to revisit treatment plans for potentially impacted patients.
5. **Stay Informed:** Monitor updates from BioMérieux and regulatory authorities for recall progress and further instructions.

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### Stay Safe – Get Instant Recall Alerts

Protect your operations and your patients by staying informed about critical recalls like this one. Timely knowledge can make all the difference in ensuring patient safety and minimizing risks in healthcare environments.

Download our **Recall Alert App** now for real-time notifications about product recalls, safety alerts, and updates across Canada. Stay ahead and make informed decisions with ease.

**[Click here to download the app today!]**

For the full recall notice, visit [the official source](https://recalls-rappels.canada.ca/en/alert-recall/vitekr-2-systems).

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This recall highlights the importance of vigilance when utilizing laboratory diagnostic systems. Acting quickly and following the provided guidelines will help reduce the risk of patient harm and support ongoing public health efforts.

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