Z-2472-2021 Class II Ongoing
FDA device recall Z-2472-2021 was initiated by Abbott Laboratories on July 26, 2021 and is designated Class II. Reason for recall: Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stabilit… The recall status is ongoing. Affected quantity: 4,833 systems.
Recall Details
- Product Type
- Devices
- Report Date
- September 22, 2021
- Initiation Date
- July 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,833 systems
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico; Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Madagascar, Malaysia, Maldives, Mauritius, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Vietnam and Zambia.