Z-0958-2023 Class III Ongoing
FDA device recall Z-0958-2023 was initiated by Abbott Laboratories on November 24, 2022 and is designated Class III. Reason for recall: Reaction vessels may contain a potential contaminant that could affect their optical performance. The recall status is ongoing. Affected quantity: 70 cases.
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2023
- Initiation Date
- November 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 cases
Product Description
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reason for Recall
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Distribution Pattern
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Code Information
UDI-DI/Lots: 00380740129026/000586790 and 000586879