Recall Z-2437-2010 ยท LCD Enzyme Immunoassay, Gentamicin
Beckman Coulter Inc.
SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitative determination of Gentamicin concentration in
| Date | Sep 20, 2010 (initiated Feb 19, 2009) |
| Status | Terminated |
| Reason | The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/mL, <3.13 umol/L) with SYNCHRON Systems Gentamicin Reagent (GEN) lot M804552. A false low result can cause a patient to receive more medication than necessary. |
| Root cause | Other |
| Action | Beckman Coulter sent an Urgent Product Corrective Action (PCA) letter dated February 27, 2009 to customers identifying the affected product and issue prompting the recall. The letter asked them to discontinue use and discard the reagent lot, and contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact their local Beckman Coulter Representative to discuss reagent replacement options. They were also asked to complete and return the enclosed response form within 10 days. Customers were directed to call the Customer Support Cen |
| Quantity | 1,547 Kits |
| Distribution | Worldwide Distribution - USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV, and countries of Canada, Belgium, Denmark, France, Germany, Ir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955644 | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM Beckman Instruments, Inc., Feb 16, 1996 |