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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity c Carbon Dioxide Reagent Kit

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  Class 2 Device Recall Alinity c Carbon Dioxide Reagent Kit see related information
Date Initiated by Firm October 23, 2019
Create Date November 26, 2019
Recall Status1 Terminated 3 on May 14, 2021
Recall Number Z-0575-2020
Recall Event ID 84140
510(K)Number K060295  
Product Classification Enzymatic, carbon-dioxide - Product Code KHS
Product Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Code Information REF # 07P7220 Lot # 54454UQ03 and  REF # 07P7230 Lot # 54449UQ03 
Recalling Firm/
Manufacturer		 Abbott GmBH & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
For Additional Information Contact US Customer Service
877-4222688
Manufacturer Reason
for Recall		 Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 10/23/19, a Product Recall letter was issued to all worldwide Alinity c Carbon Dioxide Reagent customers who received the in-date lots. US customers were sent this information via FedEx priority overnight. Customers are asked to immediately discontinue use and destroy product from LN 07P7230 lot 54449UQ03. For LN 07P7220 lot 54454UQ03, the product may continue to be used but 2 levels of CO2 controls must be run every hour until the new material is received. If you or any of the health care providers you serve have any questions regarding this information, US Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the US , please contact your local area Customer Service.
Quantity in Commerce 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
Distribution Worldwide and US Nationwide in the states of: AL, AR, CA, CO, FL, GA, ID, IL, LA, MA, MI, MN, MO, NC, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico Foreign: AUSTRALIA, BANGLADESH, BELGIUM, BOTSWANA, BRAZIL, CANADA, COLOMBIA, DENMARK, FRANCE, GREECE, Hong Kong, INDIA, ITALY, JAMAICA, LEBANON, MAURITIUS, NAMIBIA, NETHERLANDS, NEW ZEALAND, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UAE, and UNITED KINGDOM
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 = KHS and Original Applicant = ABBOTT LABORATORIES
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