Device product
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Z-0958-2023
Product summary
- Event
- Event 91303
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 70 cases
- Official record key
device-enforcement:Z-0958-2023
Official wording
Reason: Reaction vessels may contain a potential contaminant that could affect their optical performance.
Code information: UDI-DI/Lots: 00380740129026/000586790 and 000586879
Distribution pattern: US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Derived failure modes
-
Unknown
Reaction vessels may contain a potential contaminant that could affect their optical performance.