Z-0948-2015 Class II Terminated
FDA device recall Z-0948-2015 was initiated by Abbott Molecular on Nov 23, 2013 and is designated Class II. Reason for recall: The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet. The recall status is terminated (terminated Dec 4, 2017). Affected quantity: 176 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 21, 2015
- Initiation Date
- Nov 23, 2013
- Termination Date
- Dec 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
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-0948-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026