Z-0634-2013 Class II Terminated
FDA device recall Z-0634-2013 was initiated by Abbott Molecular on Dec 4, 2012 and is designated Class II. Reason for recall: An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details… The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 215 units - U.S., 693 units - ROW.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 9, 2013
- Initiation Date
- Dec 4, 2012
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215 units - U.S., 693 units - ROW
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Algeria, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Burkina Faso, Burundi, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ethiopia, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam and Zambia
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-0634-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026