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U.S. Department of Health and Human Services

Class 3 Device Recall Alinity and ARCHITECT Reaction Vessels

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  Class 3 Device Recall Alinity and ARCHITECT Reaction Vessels see related information
Date Initiated by Firm November 24, 2022
Date Posted January 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-0958-2023
Recall Event ID 91303
510(K)Number K170317  
Product Classification System, test, human chorionic gonadotropin - Product Code DHA
Product Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Code Information UDI-DI/Lots: 00380740129026/000586790 and 000586879
Recalling Firm/
Manufacturer		 Abbott Laboratories
1915 Hurd Dr
Irving TX 75038
For Additional Information Contact
972-518-6000
Manufacturer Reason
for Recall		 Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA Determined
Cause 2		 Material/Component Contamination
Action 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.
Quantity in Commerce 70 cases
Distribution US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DHA and Original Applicant = ABBOTT LABORATORIES
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