Recall Z-1545-2018— Becton Dickinson & Co.
Class III · Terminated
Class III FDA medical device recall by Becton Dickinson & Co., initiated 2018-03-02, terminated 2018-07-02. FDA's recall record names no specific 510(k) clearance for this event. Product: BD MAX DNA MMK Lab Use, catalog no. 442828. 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-03-02
- Terminated
- 2018-07-02
- Firm location
- Sparks, MD, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.