8-K: Current report filing
Published on July 23, 2003
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
Date of Report (Date of earliest event reported) July 23, 2003
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BECTON, DICKINSON AND COMPANY
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(Exact name of registrant as specified in its charter)
New Jersey 001-4802 22-0760120
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(State or other juris- (Commission (IRS Employer Iden-
diction of incorporation) File Number) tification Number)
1 Becton Drive, Franklin Lakes, New Jersey 07417-1880
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (201) 847-6800
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N/A
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(Former name or former addresses if changed since last report.)
Item 9. Regulation FD Disclosure.
The following statement is being furnished by the Company under the provisions
of Regulation FD:
BD (Becton, Dickinson and Company) announced on July 23, 2003 that it
is conducting a voluntary recall in Canada of three lots of BD'TM' Test
Strips that were manufactured for use with the BD Latitude'TM' Diabetes
Management System. The distribution of these three lots was limited to
Canada, and represents a small percentage of total BD'TM' Test Strips
produced to date.
The costs anticipated with recalling these three lots are not expected
to be significant and will be reflected in the Company's third quarter
results for the period ended June 30, 2003. The sales value of the
BD'TM' Test Strips being recalled in Canada is approximately U.S.
$400,000. Total sales of BD'TM' Test Strips in the U.S. and Canada for
the first half of BD's fiscal year 2003, for use with the BD
Latitude'TM' Diabetes Management System and the BD Logic'TM' Blood
Glucose Monitor, were approximately $5 million.
BD is taking this action following an internal quality review, which
determined that test strips from these three lots did not meet all of
BD's quality and performance specifications. The potential issues
presented by test strips from these lots relate primarily to the
accuracy of readings at low blood glucose levels, especially for
asymptomatic hypoglycemic patients. BD has not received any reports of
serious injury resulting from inaccurate readings from test strips in
these lots.
The Company is advising the U.S. Food and Drug Administration (FDA) and
Health Canada of this corrective action. BD is continuing its quality
review of its BD'TM' Test Strips, will work with the FDA and Health
Canada in connection with the issues associated with this announced
recall and market notification process, and will take any other
corrective actions that may be required.
This report may contain certain forward-looking statements (as defined
under Federal securities laws) regarding BD's performance, including
future revenues, products and income, or events or developments that BD
expects to occur or anticipates occurring in the future. All such
statements are based upon current expectations of BD and involve a
number of business risks and uncertainties. Actual results could vary
materially from anticipated results described, implied or projected in
any forward-looking statement. Factors that could cause actual results
to vary materially from any forward-looking statement include, but are
not limited to: competitive factors; pricing and market share
pressures; uncertainties of litigation; BD's ability to achieve sales
and earnings forecasts, which are based on sales volume and product mix
assumptions, to achieve its cost savings objectives, and to achieve
anticipated synergies and other cost savings in connection with
acquisitions; changes in regional, national or foreign economic
conditions; increases in energy costs; fluctuations in costs and
availability of raw materials and in BD's ability to maintain favorable
supplier arrangements and relationships; changes in interest or foreign
currency exchange rates; delays in product introductions; and changes
in health care or other governmental regulation, as well as other
factors discussed in this report and in BD's filings with the
Securities and Exchange Commission. BD does not intend to update any
forward-looking statements.
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.
BECTON, DICKINSON AND COMPANY
(Registrant)
By: /s/ Gary DeFazio
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Gary DeFazio
Assistant Secretary
Date: July 23, 2003
STATEMENT OF DIFFERENCES
The trademark symbol shall be expressed as.................. 'TM'