Recall Z-2136-2020 ยท JFL Ph Rate Measurement, Carbon-Dioxide
Beckman Coulter Inc.
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.
| Date | May 28, 2020 (initiated Jan 29, 2020) |
| Status | Terminated |
| Reason | 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 | 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 r |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS Beckman Coulter, Inc., Nov 12, 2004 |