Z-0461-2022 Class II Ongoing
FDA device recall Z-0461-2022 was initiated by Abbott Molecular, Inc. on December 6, 2021 and is designated Class II. Reason for recall: There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. The recall status is ongoing. Affected quantity: 742 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 12, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 742 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.