Import Alert 75-02
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).
Import Alert # 75-02
Published Date: 10/12/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination and Increased Surveillance Of Blood Glucose Test Strips"
Reason for Alert:
Lifescan manufactures, for export only, certain blood glucose test strips that are calibrated to be "plasma equivalent." These strips do not have FDA premarket clearance or approval. FDA investigations revealed, however, that these test strips are being imported into the United States by other companies.
Roche Diagnostics manufactures, for export only, certain blood glucose test strips that are calibrated to be "whole blood equivalent." These strips do not have FDA premarket clearance or approval. FDA investigations revealed, however, that these test strips are being imported into the United States by other companies.
Roche Diagnostics manufactures, for export only, certain blood glucose test strips that are calibrated to be "whole blood equivalent." These strips do not have FDA premarket clearance or approval. FDA investigations revealed, however, that these test strips are being imported into the United States by other companies.
Guidance:
Districts may detain, without physical examaintion, the following blood glucose test strips:
OneTouch Basic, OneTouch Profile, and OneTouch II strips, manufactured by Lifescan that are calibrated to be plasma equivalent. The outer carton packaging for these products b(1) . Plasma equivalent calibration may be confirmed in the package inserts for the products. These products may also be labeled as "not for sale in the United States" or with a similar statement indicating that they are for export only and not to be sold in the United States. In some cases, stickers may have been placed over this designation.
Accu-Chek test strips, manufactured by Roche Diagnostics that are calibrated to be whole blood equivalent. It is our understanding that the outer carton packaging for these products b(1) Whole blood equivalent calibration may be confirmed in the package inserts for the products. These products may also be labeled as "not for sale in the United States" or with a similar statement indicating that they are for export only and not to be sold in the United States. In some cases, stickers may have been placed over this designation.
Continued surveillance of blood glucose test strips from all foreign shippers appears to be warranted.
Consult DIOP and the Center for Devices and Radiological (HFZ-440) for questions concerning whether detention is warranted.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology of Field Science at 301 796-6600.
OneTouch Basic, OneTouch Profile, and OneTouch II strips, manufactured by Lifescan that are calibrated to be plasma equivalent. The outer carton packaging for these products b(1) . Plasma equivalent calibration may be confirmed in the package inserts for the products. These products may also be labeled as "not for sale in the United States" or with a similar statement indicating that they are for export only and not to be sold in the United States. In some cases, stickers may have been placed over this designation.
Accu-Chek test strips, manufactured by Roche Diagnostics that are calibrated to be whole blood equivalent. It is our understanding that the outer carton packaging for these products b(1) Whole blood equivalent calibration may be confirmed in the package inserts for the products. These products may also be labeled as "not for sale in the United States" or with a similar statement indicating that they are for export only and not to be sold in the United States. In some cases, stickers may have been placed over this designation.
Continued surveillance of blood glucose test strips from all foreign shippers appears to be warranted.
Consult DIOP and the Center for Devices and Radiological (HFZ-440) for questions concerning whether detention is warranted.
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology of Field Science at 301 796-6600.
Product Description:
Blood glucose test strips:
OneTouch® Basic, OneTouch Profile, and OneTouch II blood glucose test strips, manufactured by Lifescan, Inc., that are calibrated to be "plasma equivalent:"
and
Accu-Chek blood glucose test strips, manufactured by Roche Diagnostics Corporation, that are calibrated to be ¿whole blood equivalent.¿
OneTouch® Basic, OneTouch Profile, and OneTouch II blood glucose test strips, manufactured by Lifescan, Inc., that are calibrated to be "plasma equivalent:"
and
Accu-Chek blood glucose test strips, manufactured by Roche Diagnostics Corporation, that are calibrated to be ¿whole blood equivalent.¿
Charge:
"These articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears that they are Class III deviceswhich do not have an approved applicationfor premarket approval in effect pursuant to Section 515(a) or an apporved application for an investigational device exemption under Section 520(g) [Adulterated, Section 502(f)(1)(B)]."
OASIS Charge Code - DIRECTIONS
and
"These articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears that its labeling appears to lack adequate directions for its intended use in that the product is labeled in International System (SI) units which are not commonly used in the United States [Misbranded, Section 502(f)(1)]."
OASIS Charge Code - DIRECTIONS
OASIS Charge Code - DIRECTIONS
and
"These articles are subject to refusal of admission pursuant to section 801(a)(3) in that it appears that its labeling appears to lack adequate directions for its intended use in that the product is labeled in International System (SI) units which are not commonly used in the United States [Misbranded, Section 502(f)(1)]."
OASIS Charge Code - DIRECTIONS
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(75 C - - GA) Glucose Oxidase, Glucose
(75 L - - FR) Glucose Dehydrogenase, Glucose
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