Microdilution Panels

• • Terminated Z-1522-2015 FDA Class II ·initiated 14 May 2014

  Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.

• 2 recalls, same reason

  • Terminated Z-1498-2012 FDA Unclassified (pre-2012) ·initiated 16 Jun 2011
  • Terminated Z-1497-2012 FDA Unclassified (pre-2012) ·initiated 16 Jun 2011

  Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels.

• • Terminated Z-1499-2012 FDA Unclassified (pre-2012) ·initiated 16 Jun 2011

  Three lots were confirmed to not meet performance claims due to random non-biological contamination which is only apparent (precipated) after inoculation of the panels

510(k) Number

K862140 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Trichrome Stain

  Class I

  FDA 510(k) K831060 Active Cleared 8 Jun 1983

• P & T Medium

  Class I

  FDA 510(k) K831059 Active Cleared 28 Apr 1983

• Immunoscan Rapid Direct Group a Strep Test

  Class I

  FDA 510(k) K854447 Active Cleared 3 Jan 1986

• Immunoscan Direct Hemophilus Influenzae Type B Tes

  Class II

  FDA 510(k) K854490 Active Cleared 27 Dec 1985

• Anaerobe Rapid Chromogenic Id Panel

  Class I

  FDA 510(k) K862332 Active Cleared 27 Aug 1986

• Autoscan W/a System

  Class I

  FDA 510(k) K854448 Active Cleared 26 Nov 1985

See all devices from American Micro Scan →