Gram Negative and Gram Positive Mic/Combo Panels

• 7 recalls, same reason

  • Terminated Z-1531-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1529-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1533-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1532-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1534-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1530-2015 FDA Class II ·initiated 8 Aug 2014
  • Terminated Z-1528-2015 FDA Class II ·initiated 8 Aug 2014

  Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.

• • Terminated Z-1524-2015 FDA Class II ·initiated 8 Apr 2014

  Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.

• • Terminated Z-0541-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008

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

510(k) Number

K870074 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Antibody Assay for Detection of Influenza B

  Class I

  FDA 510(k) K871231 Active Cleared 26 Jun 1987

• Antibody Assay for Detection of Adenovirus in Cell

  Class I

  FDA 510(k) K871229 Active Cleared 26 Jun 1987

• Immunoscan(Tm) Direct Neisseria Meningitidis Kit

  Class II

  FDA 510(k) K870089 Active Cleared 17 Mar 1987

• Antibody Assay for Detec. of Resp. Syncytial Virus

  Class I

  FDA 510(k) K871230 Active Cleared 26 Jun 1987

• Antibody Assay for Detection of Influenza a

  Class I

  FDA 510(k) K871233 Active Cleared 26 Jun 1987

• Rabbit Kidney Culture Cells (First Pass)

  Class I

  FDA 510(k) K871033 Active Cleared 31 Mar 1987

See all devices from Microscan Div. Baxter Healthcare Corp. →