BD MAX DNA MMK Lab Use — Class III medical device recall Z-1545-2018
Terminated recall by Becton Dickinson & Co., reported 2018-05-09, distributed in CA, FL, NJ, NY, OR, PA, VA, WI. The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution
| Recall number | Z-1545-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2018-03-02 |
| Classified | 2018-04-28 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-07-02 |
| Distributed | CA, FL, NJ, NY, OR, PA, VA, WI |
| Countries outside the US | AR, AU, BR, CA, CL, CN, CO, HK, JP, SG, TH, TW |
| Reason classes | potency |
| Model numbers | 442828 |
Product
BD MAX DNA MMK Lab Use, catalog no. 442828
Reason for recall
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
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-1545-2018. 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.