Microscan Synergies Plus Gram Negative Mic/Combo Panels with Imipenem (0.25, 1-32 Ug/Ml)

• 11 recalls, same reason

  • Terminated Z-2129-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2126-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2124-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2122-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2128-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2123-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2120-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2127-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2121-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2119-2013 FDA Class I ·initiated 21 Aug 2013
  • Terminated Z-2125-2013 FDA Class I ·initiated 21 Aug 2013

  Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.

• • Terminated Z-0540-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008

  Falsely lowered imipenem MICs may result, leading to major errors in results.

510(k) Number

K020246 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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