Z-0462-2022 Class II Terminated
FDA device recall Z-0462-2022 was initiated by Abbott Molecular, Inc. on Dec 6, 2021 and is designated Class II. Reason for recall: There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. The recall status is terminated (terminated Aug 14, 2026). Affected quantity: 742 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 12, 2022
- Initiation Date
- Dec 6, 2021
- Termination Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 742 devices
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US distribution 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
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-0462-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026