UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

June 1, 2010

Date of Report (Date of Earliest Event Reported)

 

 

BECKMAN COULTER, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-10109   95-104-0600
(State of Incorporation)  

(Commission

File Number)

 

(IRS Employer

Identification Number)

250 S. Kraemer Boulevard

Brea, California 92822

(Address of Principal Executive Offices) (Zip Code)

(714) 993-5321

(Registrant’s Telephone Number, Including Area Code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01. Other Events.

Beckman Coulter Updates its Outlook for Troponin Testing on its Access Immunoassay Instruments

As Beckman Coulter, Inc. (the “Company,” “our”, “us” or “we”) has previously disclosed, FDA has indicated to us that it believes certain modifications to our troponin test as used on Access immunoassay instruments were made without providing the agency with an opportunity to review those modifications. FDA has now informed us that they intend to allow us to continue to provide the troponin test kits to customers currently using Access instruments for troponin testing throughout the period required to perform the clinical trial described below. We are continuing our discussions with FDA and expect to implement a monitoring program to assure the performance of the test. We continue to believe that we will not be able to provide troponin test kits to U.S. customers that are not currently performing troponin testing on Access instruments until we obtain an updated 510(k) clearance.

Based on our discussions with FDA, we are planning to conduct a prospective clinical study and to submit two separate 510(k) submissions for our troponin test in the first half of 2011 - one for Access instruments and one for DxI instruments. The study will be designed to establish the diagnostic performance of the test using patient samples from the intended use population. We are working collaboratively with FDA on a study protocol that will expedite the execution of the study.

Forward-Looking Statements

This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements contain words such as “expect,” “estimate,” “could,” “will,” “likely,” “possible,” “may” or the negative thereof or comparable terminology, and may include information regarding the company’s expectations, goals or intentions regarding the future.

Forward-looking statements included herein are based on management’s current expectations, estimates, forecasts and projections about the Company and are subject to risks and uncertainties, some of which may be beyond the Company’s control that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include that 510(k) clearances for our products could be lengthy and costly and may require the withdrawal of product from the market until such clearances are obtained and the imposition of recalls or the initiation of enforcement actions against us by FDA, including warning letters, fines, seizures, consent orders or injunctions. In addition, our internal review of our products could reveal failures in our processes and systems which could be significant, the loss of revenue from our products that are the subject of FDA inquiries could be more than we estimate, including the risk that foreign sales could also be adversely affected, that these issues could cause us to lose customers and there could be unanticipated costs associated with these matters or other discussions with FDA. Additional factors that could cause actual results to differ are discussed in the Company’s 2009 Form 10-K and the Company’s Form 10-Q for the quarter ended March 31, 2010 as well as in reports the Company files with the Securities and Exchange Commission from time to time. Forward-looking statements contained herein are made only as of the date hereof, and we undertake no obligation to update these disclosures except as required by law.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    BECKMAN COULTER, INC.
Date: June 1, 2010     By:  

/S/    ARNOLD A. PINKSTON        

    Name:   Arnold A. Pinkston
    Title:   Senior Vice President, General Counsel and Secretary