Z-1772-2026Class II

MicroScan Neg MIC 3J REF C54814

Name: Z-1772-2026 MicroScan Neg MIC 3J REF C54814
Creator: Beckman Coulter, Inc.
Published: 2025-06-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of MicroScan Neg MIC 3J REF C54814 on 2025-06-25. FDA classified it as Class II and gives the reason as "Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics". 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-1772-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-25
Posted: 2026-04-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan Neg MIC 3J REF C54814
Product code: LTT Panels, Test, Susceptibility, Antimicrobial
Reason for recall: Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 07/15/2024, firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customer inform them that customers have reported multiple patient samples with skipped wells for Ceftolozane/Tazobactam (C/T) when tested with MicroScan Neg MIC 3J Lot 2025-08-23. The C/T 2/4 dilution well exhibited no growth while growth was observed in the C/T 4/4 well. Customers are instructed to: "Discontinue use of this lot and discard per your laboratory guidelines. "Consider reviewing the C/T antimicrobial susceptibility test results from this lot if Enterobacterales reported as resistant and P. aeruginosa reported as intermediate or if an increasing trend in resistance has been observed for C/T in your laboratory. "The laboratory should retain the inventory of other MicroScan Neg MIC 3J lots as they are not impacted by this issue. any questions regarding this notice, please contact us: "From our website: http://www.beckmancoulter.com "By phone: please contact: Customer call center TEL :0120-566-730
Quantity in commerce: 688 boxes (20 panels per box)
Distribution: International distribution in the country of Japan.
Product codes and lots: Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1772-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1772-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-03

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)