Z-2437-2010

SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel...

Name: Z-2437-2010 SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel...
Creator: Beckman Coulter Inc.
Published: 2009-02-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-02-19 / Terminated

FDA source

Beckman Coulter Inc. began a recall of 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... on 2009-02-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2437-2010
Status: Terminated
Initiated: 2009-02-19
Posted: 2010-09-20
Terminated: 2012-07-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: LCD Enzyme Immunoassay, Gentamicin
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.
FDA 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 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.
Product codes and lots: Lot Number M804552

Product code LCD

K955644Class IISynchron Systems Carbamazepine Test SystemBeckman Instruments, Inc. / cleared 1996-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)