—#181026

Product

ISE 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.

FDA product code: JFL — Ph Rate Measurement, Carbon-Dioxide
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K042291
Affected lot / code info: Lot Number: M909206

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

An 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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2020-01-29
Posted by FDA: 2020-05-28
Terminated: 2021-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.