ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quanti

FDA device recall Z-2136-2020 · posted 2020-05-28 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

JFL

Quantity affected

2738 vials

Distribution

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, V

Date initiated

2020-01-29

Date posted

2020-05-28

Date terminated

2021-04-28

Location

Brea, CA

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