Class 2 Device Recall iSTAT cTnI cartridge

• Date Initiated by Firm: October 16, 2019
• Create Date: December 31, 2019
• Recall Status: Terminated on May 04, 2020
• Recall Number: Z-0761-2020
• Recall Event ID: 84166
• 510(K)Number: K031739 K051433
• Product Classification: Immunoassay method, troponin subunit - Product Code MMI
• Product: i-STAT cTnI cartridge
• Code Information: List Number: 06P23-25 UDI: (01)00054749001986
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: 609-454-9000
• Manufacturer Reason for Recall: i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
• FDA Determined Cause: Device Design
• Action: On October 16, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail. It explains Abbott Point of Care has made the decision to transition U.S. customers using the i-STAT cTnI blue cartridge, list number 06P23-25, to the i-STAT cTnI white cartridge, list number 03P90-25, beginning in November 2019. The i-STAT cTnI blue cartridge, list number 06P23-25, will be discontinued for sale in the United States as of January 1, 2020. It further explains to customers while the i-STAT cTnI blue cartridges can continue to be used for patient testing, APOC recommends that all users of the i-STAT System be informed of the possibility of a higher than expected number of quality check codes while using the i-STAT cTnI blue cartridge and maintain a validated alternate backup method until the i-STAT cTnI white cartridges are received. Your Abbott Point of Care representative will contact you to discuss the details and timing of this transition for your facility. If your facility repeatedly observes the i-STAT cTnI blue cartridges from a single lot generating a higher than expected number of QCCs, please contact APOC Technical Services for support and to report the information. If you have forwarded any i-STAT cTnI blue cartridges to another facility, please provide a copy of this letter to them. ADDITIONAL INFORMATION If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-866-324-8114, or via email at apoc_cTnIproductinfo@abbott.com or contact your Abbott Point of Care support services representative. We appreciate your understanding in this matter and thank you for your continued support of Abbott and Abbott products.
• Quantity in Commerce: 3,465,875
• Distribution: US: AK AL AZ CA CT DC FL GA HI IL IN KS KY MD MI MS NC NE NH NM NV NY OH OK OR PA SC SD TN TX VA WA WV WY
• 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 = MMI