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Class 2 Device Recall SYNCHRON Gentamicin (GEN) Reagent |
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Date Initiated by Firm |
February 19, 2009 |
Date Posted |
September 20, 2010 |
Recall Status1 |
Terminated 3 on July 16, 2012 |
Recall Number |
Z-2437-2010 |
Recall Event ID |
53044 |
510(K)Number |
K955644
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Product Classification |
Enzyme immunoassay, gentamicin - Product Code LCD
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Product |
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 |
Code Information |
Lot Number M804552 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
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For Additional Information Contact |
714-993-5321
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Manufacturer 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.
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FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
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, Ireland, Lithuania, Netherlands, Spain, Switzerland, United Kingdom, New Zealand, Singapore, Egypt, South Africa, Taiwan, and United Arab Imarets. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LCD and Original Applicant = BECKMAN INSTRUMENTS, INC.
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