CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
BD Bactec Mgit 960 Pza Kit)- Ivd qualitative procedure recalled
Becton Dickinson & is recalling BD Bactec Mgit 960 Pza Kit)- Ivd qualitative procedure for susceptibility testing of, distributed nationwide in the US. The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2686-2024
- FDA event ID
- 95023
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2024
- FDA classified
- 16 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2024 | Recall initiated by company | |
| 16 Aug 2024 | Classified by FDA | +29 days |
| 28 Aug 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Vietnam.
Questions about this recall
Is BD Bactec Mgit 960 Pza Kit)- Ivd qualitative procedure for susceptibility testing of recalled?
Yes. Becton Dickinson & recalled BD Bactec Mgit 960 Pza Kit)- Ivd qualitative procedure for susceptibility testing of on 18 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-2686-2024.
Why was it recalled?
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
Which lots are affected?
UDI-DI: (01) 0038290245128 Lot Numbers: Amended 8/1/24 3104416 3156654 3191569 3233971 3241654 3248314 3269157 3298311 3298317 3304389 3324422 3338965 4002353 4009894 4036330 4051247
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brunei, Brazil, Canada, China, Costa Rica, Dominican Republic, Guatemala, Guyana, Hong Kong, Haiti, Indonesia, India, Japan, Korea, Myanmar, Macau, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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