Z-2136-2020Class II

ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -

Name: Z-2136-2020 ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 -
Creator: Beckman Coulter Inc.
Published: 2020-01-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-01-29 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide... on 2020-01-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2136-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-29
Posted: 2020-05-28
Terminated: 2021-04-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JFL Ph Rate Measurement, Carbon-Dioxide
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 commerce: 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, VA, WA, WI, WV and the countries of CANADA, JAPAN, LEBANON, SAUDI ARABIA, TAIWAN.
Product codes and lots: Lot Number: M909206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28

Product code JFL

K042291Class IIUnicel Dxc 600 and 800 Synchron SystemsBeckman Coulter, Inc. / cleared 2004-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)