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U.S. Department of Health and Human Services

Import Alert 80-02
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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 # 80-02
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Exam Of Clinical Mercury-In-Glass Thermometers For Failure To Meet Accuracy Requirements"

Reason for Alert:
Florida district, Miami resident post, sampled a shipment of mercury-in-glass thermometers. The Winchester Engineering and Analytical Center found that one (1) thermometer out of 24 failed to meet accuracy requirements at two (2) test points and 8 out of 24 thermometers failed to meet accuracy requirements at one (1) test point. The sample was not consistent with the accuracy guidelines found in CPG 335.800

Guidance:
Districts may detain, without physical sampling and analysis, entries of mercury-in-glass thermometers from firms in the attachment to this alert.

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.

Product Description:
Clinical Mercury-In-Glass Thermometers

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that its quality falls below that which it purports or is represented to possess [Adulterated, 21 U.S.C. 501(c)]."

OASIS charge code - DR QUALITC

Countries

CHINA
(80 F - - LK) Thermometer, Clinical Mercury
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