Z-0934-2019 Class II Terminated
FDA device recall Z-0934-2019 was initiated by Becton Dickinson & Co. on Dec 20, 2018 and is designated Class II. Reason for recall: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. The recall status is terminated (terminated Apr 10, 2020). Affected quantity: 62880 total.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Apr 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62880 total
Product Description
Reason for Recall
Distribution Pattern
The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0934-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026