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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott iSTAT CG8

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  Class 2 Device Recall Abbott iSTAT CG8 see related information
Date Initiated by Firm December 22, 2020
Create Date January 19, 2021
Recall Status1 Terminated 3 on September 01, 2023
Recall Number Z-0880-2021
Recall Event ID 87073
510(K)Number K940918  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood

List Number: 03P88-25
Code Information Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y  Primary GTIN (01) 00054749000163)
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Stephanie Radek
224-668-0164
Manufacturer Reason
for Recall		 Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
FDA Determined
Cause 2		 Under Investigation by firm
Action Abbott Point of Care notified Customers via email beginning on 22 December 2020. Customer letters will begin shipping via FedEx on 28-December-2020 for delivery on or around 29-December-2020. Letter states reason for recall, health risk and action to take: While Abbott Point of Care continues to investigate this issue, if reporting ionized calcium is required, it is recommended that the i-STAT CG8+ and EG7+ cartridges be used only: within 3 days of removal from refrigerated storage for lot numbers between *20100 and *20339 within 7 days of removal from refrigerated storage for lot numbers *20340 and above Where *= lot letter A, K, L, M, N, W and Y If your facility is unable to manage to the recommended action outlined above, Abbott Point of Care recommends that your facility disable and not report the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges and use an alternate i-STAT cartridge or method for reporting ionized calcium. Please see additional information below on how to disable the ionized calcium test for these cartridges. Please confirm receipt and understanding of this communication by responding to the business reply form included with this letter. Additional information regarding potential solutions will be provided separately by APOC. If you have forwardedany i-STAT CG8+ and EG7+ cartridges to another facility, we request that you please provide a copy of this letter to them. Your Abbott Point of Care sales and support team will be contacting you to review interim solutions for the challenges this communication may bring. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 1-844-256-9531, or via email at apoc_productinformation@abbott.com or visit the Abbott Point of Care website www.pointofcare.abbott. Additionally, please report any questions or concerns about the performance of the ionized calcium test on the i-STAT CG8+ and EG7+ cartridges to Abbott Point of Care Tec
Quantity in Commerce 2,820,000 cartridges US and 2,273,453 catridges OUS
Distribution Nationwide
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 = CHL and Original Applicant = I-STAT CORP.
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