IA #75-01, 01/19/01 - REVISION OF IMPORT ALERT #75-01, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF URINE TEST STRIPS NOT LABELED FOR MARKETING IN THE
UNITED STATES" ATTACHMENT REVISED 2/9/01


(NOTE:  This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(s) at issue.  It
does not create or confer any rights for or on any person, and does not
operate to bind FDA or the public.)

PRODUCT        :    Urine Test Strips

PRODUCT CODE   :    75DHA, 75JJB

PROBLEM        :    MISBRANDING

PAF (Problem
     Area Flag)     :    LBL (Labeling)

PAC FOR
COLLECTION          :    82008

COUNTRY        :    See Attachment

MANUFACTURER
 and FEI       :    See Attachment

SHIPPER
 and FEI       :    See Attachment


CHARGE         :    "The article is subject to refusal of admission
                    pursuant to section 801(a)(3) in that its labeling
                    appears to lack adequate directions for its intended
                    use, in that product is labeled in International
                    System (SI) units which are not commonly used in the
                    United States" [Misbranding, 502(f)(1)]

OASIS CHARGE
CODE           :    DIRECTIONS

RECOMMENDING
OFFICE         :    Center for Devices & Radiological Health/OC/DOE I/HFZ-
                    300

REASON FOR
ALERT               :    The Center for Devices and Radiological Health (CDRH)
                         has received numerous complaints involving urine test
                         strips which are labeled for sale in Canada but are
                         being commercialized in the United States.  These
                         urine test strips are being used for various tests
                         such as: Glucose, Bilirubin, Protein, Ketone, Nitrite,
                         and Leucocites.

                    These products are intended for sale in Canada and
                    they are labeled in the International System (IS) of
                    units which are used and recognized in Canada.
                    Because these metric units are not commonly used in
                    the United States, consumers in this country may not
                    appropriately convert and interpret the results.

GUIDANCE       :    Districts may detain without physical examination
                    urine test strips manufactured by firms on the
                    attachment of this import alert.

                    Continued surveillance of urine test strips from other
                    foreign manufacturers appears warranted.

                    For questions or issues concerning science, science
                    policy, sample collection, analysis, preparation, or
                    analytical methodology, contact the Division of Field
                    Science at (301) 443-3320 or 3007.

PRIORITIZATION
GUIDANCE       :    N/A

FOI            :    No purging is required.

KEYWORDS       :    urine test strips, International System, International
                    Units

PREPARED BY         :    Jack Geltman, Opns. & Policy Br., DIOP, HFC-172,
                         (301)443-6653

DATE LOADED
INTO FIARS          :    January 19, 2001


                                              ATTACHMENT TO IA 75-01 REVISED 2/9/01

          FIRMS/PRODUCTS THAT MAY BE SUBJECT TO DWPE

                         GREAT BRITAIN

MANUFACTURER                  PRODUCT

Bayer Diagnostics             Labstix (Urianalysis Reagent Strips)
Bayer House, Strawberry  Uristix 4/
Brookshire               75JJB
United Kingdom                1/19/01
FEI #3001267546

                    Urinalysis Controls
                    75JJW
                    2/9/01

          SHIPPER
          Sensor Health Products, Inc.
          60 Harwood Road
          Cambridge, Ontario
          Canada
          FEI #3001182062