SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 S

FDA device recall Z-2437-2010 · posted 2010-09-20 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

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.

Root cause

Other

Status

Terminated

Product code

LCD

Quantity affected

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

Date initiated

2009-02-19

Date posted

2010-09-20

Date terminated

2012-07-16

Location

Brea, CA

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