Z-1794-2026Class II

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with...

Name: Z-1794-2026 MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with...
Creator: Beckman Coulter, Inc.
Published: 2025-09-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-09-08 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and... on 2025-09-08. FDA classified it as Class II and gives the reason as "Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1794-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-08
Posted: 2026-04-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
Reason for recall: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On 09/08/2025, the firm sent via mail/email an "URGENT FIELD SAFETY NOTICE" to customers informing them that as a result of an internal investigation Beckman Coulter confirmed that Ciprofloxacin (Cp) antimicrobial agent was incorrectly manufactured on MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08. Customers are instructed to: "Review Ciprofloxacin results generated from Lot 2026-05-08 to identify any abnormal or unexpected trends in both susceptible and resistance patterns, or unexpected change in MIC trends, as compared to historical results for that same species (e.g. a sudden, unexplained increase in susceptible or % susceptible results for a species after implementation of Lot 2026-05-08 versus the previous susceptible or % susceptible results for the same species prior to using Lot 2026-05-08). "Discontinue use of this lot and discard per your laboratory guidelines "The laboratory should retain the inventory of other MicroScan Neg Multidrug Resistant MIC 1 lots as they are not impacted by this issue. Note-Beckman Coulter is no longer distributing MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08 For questions - contact Customer Support Center from website: http://www.beckmancoulter.com
Quantity in commerce: 3 boxes
Distribution: International distribution to the country of Poland.
Product codes and lots: Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-08

Product code LTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)