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
This recall has been terminated (originally issued September 20, 2010).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- February 19, 2009
- Posted
- September 20, 2010
- Terminated
- July 16, 2012
- Recall Number
- Z-2437-2010
- Quantity
- 1,547 Kits
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, Ireland, Lithuania, Netherlands, Spain, Switzerland, United Kingdom, New Zealand, Singapore, Egypt, South Africa, Taiwan, and United Arab Imarets.
Lot / Code Info
Lot Number M804552
Root Cause
Other
Action Taken
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 Center (Hotline) at (800) 854-3633 in the US and Canada if they had questions in regards to the PCA letter. Outside the US and Canada they were told to contact their local Beckman Coulter Representative.