Class 2 Device Recall ARCHITECT Instrument

• Date Initiated by Firm: September 29, 2017
• Create Date: November 21, 2017
• Recall Status: Completed
• Recall Number: Z-0165-2018
• Recall Event ID: 78225
• 510(K)Number: K980367
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
• Code Information: c400073, c400103, c400498, c400600, c400890, c400934, c400935, c401018, c401055, c401056, c401182, c401505, c401520, c401686, c401887, c460196, c460200, c460943, c461550, c803669, c803753, c1600144, c1600249, c1600251, c1600641, c1600720, c1600819, c1600859, c1600976, c1601350, c1601351
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: Customer Service; 972-518-6001
• Manufacturer Reason for Recall: The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
• FDA Determined Cause: Component design/selection
• Action: All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected consignees.
• Quantity in Commerce: 34 units
• Distribution: Worldwide distribution to US, Canada, France, and Germany.
• 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.

• 510(K) Database: 510(K)s with Product Code = JJE