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U.S. Department of Health and Human Services

Class 2 Device Recall SYNCHRON Systems ISE Electrolyte Reference Reagent

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 Class 2 Device Recall SYNCHRON Systems ISE Electrolyte Reference Reagentsee related information
Date Initiated by FirmJanuary 29, 2020
Date PostedMay 28, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-2136-2020
Recall Event ID 85467
510(K)NumberK042291 
Product Classification pH rate measurement, carbon-dioxide - Product Code JFL
ProductISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
Code Information Lot Number: M909206
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactCustomer Support Center
714-961-5321
Manufacturer Reason
for Recall		Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.
FDA Determined
Cause 2		Process control
ActionAn Urgent Medical Device Recall letter, dated January 23, 2020 was sent on 01/29/2020 to the affected customers via first class mail and/or email. Customers are advised to: 1) Discontinue use of all ISE Electrolyte Reference Reagent lot M909206 kits. 2) Please review the product Safety Data Sheet (SDS) and discard all ISE Electrolyte Reference Reagent lot M909206 kits according to your laboratorys Standard Operating Procedures and/or according to local regulations. The SDS is available for viewing, printing, and download at https://www.beckmancoulter.com/support/tech-docs. 3) Retrospective review of results is not required. CO2 results are acceptable after a successful calibration and when quality control recoveries are within your laboratorys established QC ranges. 4) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that they are assured customers have received this important communication, they request response within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If customers have any questions regarding this notice, please contact Customer Support Center: " From website: http://www.beckmancoulter.com/customersupport/support " By phone: call 1-800-854-3633 in the United States and Canada. " Outside the United States, contact your local Beckman Coulter Representative. If you need replacement product: " For customers in the United States: o Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821 " For customers in Canada: o Complete the attached Replacement Order Form and email to Beckmancoultercanada@be
Quantity in Commerce2738 vials
DistributionWorldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries of CANADA, JAPAN, LEBANON, SAUDI ARABIA, TAIWAN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JFL
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