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MicroScan D18443

by Beckman Coulter, Inc. United States GUDID

Product code JWY

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099590798970 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

5 recalls · 1 ongoing · FDA

    • Ongoing Z-1609-2026 FDA Class II initiated 24 Jul 2025

    Due to the likely presence of contamination in well(s).

    • 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

Specification

GUDID · synced 23 Oct 2026

Trade Name
MicroScan
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD
Model / Ref / Catalog
D18443
Primary DI / UDI-DI
15099590798970
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 3fe382f1-6b4d-457e-9f77-9f847301a82e 35 fields · synced 23 Oct 2026