Import Alert 75-01

"Detention Without Physical Examination Of Urine Test Strips Not Labeled for Marketing in the U.S."

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.

Districts may detain, without physical examination, urine test strips manufactured by firms identified in the attachment for 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 301 796-6600.

Urine Test Strips.

"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