BD PCR Cartridges used with MAX System — Class II medical device recall Z-1004-2025
Ongoing recall by Becton Dickinson & Co., reported 2025-01-29, distributed nationwide. Potential for signal drift in specific lots of BD PCR Cartridges.
| Recall number | Z-1004-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-12-19 |
| Classified | 2025-01-21 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CL, HK, IN, JP, KR, MX, PH, SG, TT, TW, UY, VN |
| Quantity | 516,435 units |
| UPC / GTIN / UDI-DI | 30382904375196 |
| Model numbers | 437519 |
Product
BD PCR Cartridges used with MAX System. Model Number: 437519
Reason for recall
Potential for signal drift in specific lots of BD PCR Cartridges.
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-1004-2025. 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.