Z-1545-2018 Class III Terminated
FDA device recall Z-1545-2018 was initiated by Becton Dickinson & Co. on Mar 2, 2018 and is designated Class III. 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… The recall status is terminated (terminated Jul 2, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Mar 2, 2018
- Termination Date
- Jul 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Distribution Pattern
Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.
Code Information
All since 08/20/2014
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1545-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026