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MicroScan D18448

by Beckman Coulter, Inc. United States GUDID

Product code JWY

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099590799021 UDI-DIDate8 Dec 2025ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

14 recalls · FDA

    • Terminated Z-2599-2018 FDA Class II initiated 4 May 2018

    The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

  • 7 recalls, same reason

    • 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
    • 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

    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-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.

    • 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.

  • 2 recalls, same reason

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

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

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

Specification

GUDID · synced 23 Oct 2026

Trade Name
MicroScan
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD
Model / Reference
D18448
Primary DI / UDI-DI
15099590799021
510(k) Number
FDA Product Code
JWY, LRG, LTT, LTW
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD
Device Class
Class II
Regulation Number
866.1640
Commercial Distribution
In Commercial Distribution

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (9)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI 06a4cd4f-a8b2-453f-8545-f68921960e7b 34 fields · synced 23 Oct 2026