Cholestech Ldx Alanine Aminotransferase (Alt), Model 11-772

• • Terminated Z-1139-2013 FDA Class II ·initiated 6 Mar 2013

  The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.

510(k) Number

K991834 ↗

FDA Product Code

CKD

Device Class

Class I

Regulation

21 CFR Part 862.1030

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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