FDA Device recall Z-1544-2018
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
- FDA Device
- Class III
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class III recall of BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1544-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-02 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, FL, NJ, NY, OR, PA, VA, WI |
Product
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
Reason
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.
Identifiers
| code_info | All since 08/20/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1544-2018%22
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