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
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