Z-2599-2018Class II

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent...

Name: Z-2599-2018 MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent...
Creator: Beckman Coulter Inc.
Published: 2018-05-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-05-04 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level... on 2018-05-04. FDA classified it as Class II and gives the reason as "The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2599-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-08-02
Terminated: 2020-08-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
Reason for recall: The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed.
Quantity in commerce: 686 boxes
Distribution: NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
Product codes and lots: Lot 2018-11-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2599-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2599-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code LTT

K020160Class IIDried Gram-Positive Mic/combo Panels with AmpicillinDade Behring, Inc. / cleared 2002-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)