Triage D-Dimer Test, Model 98100

• • Terminated Z-1727-2014 FDA Class II ·initiated 2 May 2014

  Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.

• • Terminated Z-1932-2012 FDA Class I ·initiated 22 May 2012

  Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.

510(k) Number

K042890 ↗

FDA Product Code

GHH

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class II

  FDA 510(k) K902924 Active Cleared 14 Sep 1990

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  Class II

  FDA 510(k) K012745 Active Cleared 10 Jan 2002

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