Class 2 Device Recall Abbott ARCHITECT cSystems ICT Module

• Date Initiated by Firm: August 28, 2018
• Create Date: May 08, 2019
• Recall Status: Terminated on September 23, 2020
• Recall Number: Z-1296-2019
• Recall Event ID: 81861
• 510(K)Number: K980367
• Product Classification: Electrode, ion-specific, chloride - Product Code CGZ
• Product: Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
• Code Information: Lot No. 180326, Exp. 12/26/2018; UDI (01)00380740019327(17)181226(10)180326(21)180326301 through (01)00380740019327(17)181226(10)180326(21)180326399
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Dr; Irving TX 75038-4313
• For Additional Information Contact: Mr. Albert Chianello; 877-422-2688
• Manufacturer Reason for Recall: There is a potential to generate falsely elevated serum or plasma chloride results when using the product.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated 8/28/2018 via overnight mail. The letter explained the issue, patient impact, and instructed the consignee to immediately discontinue use of the product and destroy any remaining inventory of the impacted lot number. The letter was to be reviewed with the Medical Director and laboratory protocol should be followed regarding the need to review previously-reported patient results. A Customer Reply Form was enclosed for the U.S. consignees to indicate the consignee understood and completed the necessary actions to be taken. For questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
• Quantity in Commerce: 99 modules/kits
• Distribution: Worldwide Distribution - US Nationwide in the states of AR, CA, CT, FL, IA, IN, LA, MA, MD, MS, NJ, NY, PA, SC, TX, VT, WA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Australia, China, Hong Kong, and New Zealand.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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