Kit BD Max ExK DNA 2 USA — Class II medical device recall Z-2325-2019
Terminated recall by Becton Dickinson & Co., reported 2019-08-28, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
| Recall number | Z-2325-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2019-07-17 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-05-13 |
| Distributed | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AU, BE, BR, CA, CL, CN, HK, JP, KR, MX, SG, TW |
| Quantity | 0 |
| UPC / GTIN / UDI-DI | 00382904428198 |
| Lot numbers | 9114654 |
| Model numbers | 442819 |
| Expiration dates | 2020-11-07 |
Product
Kit BD Max ExK DNA 2 USA; Catalog # 442819
Reason for recall
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
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-2325-2019. 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.