Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Abbott ARCHITECT cSystems ICT Module

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Abbott ARCHITECT cSystems ICT Module see related information
Date Initiated by Firm August 28, 2018
Create Date May 08, 2019
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ABBOTT LABORATORIES
-
-