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08/16/2024: Lab Alert: BD Life Sciences Issues Notice to Immediately Discard Affected BD BACTEC MGIT 960 PZA Kits
Audience: Clinical Laboratory Professionals
Level: Laboratory Alert
On August 1, 2024, BD sent an urgent Medical Device Correction update regarding the removal of affected BD BACTEC™ MGIT™ 960 PZA Kits. Through internal BD complaint trending and review of internal raw material testing, lots of BD BACTEC™ MGIT™ 960 PZA Kits were identified that may intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates. The current list of affected lots can be found here.
Pyrazinamide (PZA) is widely used for the treatment of tuberculosis and its exclusion based on false resistance results can result in a less optimal treatment regimen, including extending the length of treatment and increased risk of medication side effects.
Laboratories should immediately inspect their inventory and destroy affected product subject to the recall following their institution’s process of destruction. There are no recommendations for retesting or reviewing previous patient test results.
Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via the following routes:
- Web: www.fda.gov/medwatch
- Phone: 1-800-332-1088
- Mail: MedWatch, HF-2, FDA, 5600 Fisher’s Lane, Rockville, MD 20852-9787
For further assistance regarding this product or the recall, please contact:
BD North American Regional Complaint Center
- Phone: 1-844-823-5433, Mon–Fri 8:00am and 5:00pm CT (Say “Complaints” when prompted)
- Email: productcomplaints@bd.com
BD Recall Related Questions
- Email: BDRC12@bd.com
For more information, please review the letter in detail.
We encourage you to share this message widely with your network(s).
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Online Resources
- URGENT: Medical Device Correction – UPDATE | BD Life Sciences
- Impacted Products: IDS-24-5091 BD BACTEC™ | BD Life Sciences
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Laboratory Systems and Response (CLSR)
Centers for Disease Control and Prevention (CDC)