Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
- Company
- Abbott Laboratories
- Recall Initiated
- November 24, 2022
- Posted
- January 17, 2023
- Recall Number
- Z-0958-2023
- Quantity
- 70 cases
- Firm Location
- Irving, TX
Reason for Recall
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Distribution
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Lot / Code Info
UDI-DI/Lots: 00380740129026/000586790 and 000586879
Root Cause
Material/Component Contamination
Action Taken
On 11/24/22, the recalling firm phoned customers and informed them of the recall using a phone script. On the same day, the phone call was followed by an email that restated the information in the phone script and included a Customer Reply form. Customers were asked to discontinue use and destroy the impacted inventory according to their laboratory procedures. If customers forwarded the product to other laboratories, they were asked to inform them of this Product Recall and complete and return the Customer Reply form, which can be returned to PMS@abbott.com. The reply form asked customers to record the number of boxes destroyed. If you have any questions, contact QA Manager, Post Market Surveillance at 224-668-0343 or email: suchin.song@abbott.com.