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