Z-2276-2021 Class II Ongoing
FDA device recall Z-2276-2021 was initiated by Abbott Laboratories, Inc on July 12, 2021 and is designated Class II. Reason for recall: A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators. The recall status is ongoing. Affected quantity: 260 systems.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- July 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 260 systems
Product Description
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
Reason for Recall
A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
Distribution Pattern
Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.
Code Information
Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330