BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for… — Class II medical device recall Z-2686-2024
Ongoing recall by Becton Dickinson & Co., reported 2024-08-28, distributed nationwide. May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of M
| Recall number | Z-2686-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-07-18 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BD, BE, BR, CA, CN, CR, DO, GT, GY, HK, HT, ID, IN, JP, KR, MX, MY, NP, NZ, PA, PE, PH, PK, SG, SV, TH, TT, TW, VN |
| Quantity | 12,383 eaches |
| Model numbers | 245128 |
Product
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Reason for recall
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2686-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.